Psychosocial eHealth in Advanced Lung Cancer

NCT05497973 | Unknown DMC

• 1 other identifier: PRYES211395OCHO
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 1

Brief Summary

Being diagnosed with cancer impairs many areas of a person's life. Although efficacious educational, emotional and social interventions exist in this regard, they often reach few survivors and late. This project, carried out by a specialized centre in cancer care and health research, will study the effectiveness, costs, and utility associated with a digital ecosystem tailored to meet the needs of patients with advanced lung cancer. This solution bridges the gap between patients and professionals to offer health services precisely when they are needed. The project is developed in the first year of an advanced lung cancer diagnosis, comparing the effects of the digital ecosystem with usual care in terms of their capacity to improve various psychosocial indicators. A comparative economic analysis will be carried out as well, to prove the cost-utility of the digital ecosystem presented.

Conditions

Lung Cancer, Nonsmall Cell, Stage IIIA; Lung Cancer Non-Small Cell Stage IIIB; Lung Cancer Non-Small Cell Stage III; Lung Cancer Stage IV; Lung Cancer

Keywords

Psychooncology; Psychosocial care; Palliative care; eHealth; Continuity of patient care; Telemedicine; Well-being; Psychosocial Functioning; Patient Engagement; Emotional Distress; Quality of Life; Health Knowledge, Attitudes, Practice; End of life care

Outcome Measures

Primary Outcomes (7)

• Changes in Emotional distress

  Emotional distress will be assessed through the Hospital Anxiety and Depression Scale (HADS; Zigmond \& Snaith, 1983). The HADS measures symptoms of anxiety and depression and consists of 14 items: seven items for the anxiety subscale (HADS Anxiety) and seven for the depression subscale (HADS Depression). HADS Anxiety focuses mainly on symptoms of generalized anxiety disorder and HADS Depression is focused on anhedonia, the main symptom of depression. Each item is scored on a response scale with four alternatives ranging between 0 and 3. Higher scores means higher levels of depression and anxiety.

  Assessment will be conducted at baseline and at 3 months, 6 months and 9 months to assess change from baseline

• Changes in Spirituality

  Spirituality will be assessed through the Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being (FACIT-Sp; Peterman et al., 2002). This scale includes factors of meaning, peace and faith, assessed through 12 items rated on a 0-4 Likert scale. The overall score ranges between 0 and 48, and between 0 and 16 for each subscale, where higher scores are indicative of greater spiritual well-being.

  Assessment will be conducted at baseline and at 3 months, 6 months and 9 months to assess change from baseline

• Changes in Demoralization

  Demoralization will be measured through the Demoralization Scale (DS-II; Kissane et al., 2004). The DS-II is a 3-point response, self-report scale comprising 16 items and 2 subscales: distress and coping ability, and meaning and purpose. Scores \<10 indicate no demoralization, between 10-19 moderate demoralization, and \>20 severe demoralization.

  Assessment will be conducted at baseline and at 3 months, 6 months and 9 months to assess change from baseline

• Changes in Adjusted LC Health-Related Quality Of Life

  Health-Related Quality Of Life (HRQOL) will be assessed through the Functional Assessment of Cancer Therapy-Lung (FACT-L; Cella et al., 1995). The FACT-L is a 36-item, lung cancer-specific instrument that also includes the symptom-based Lung Cancer Sub-scale (LCS). It has 36 items organized into 5 subscales: 1) physical well-being, 2) functional well-being, 3) social/family well-being, 4) emotional well-being and 5) lung cancer. Responses are scored on a Likert-type scale ranging from 0 (not at all) to 4 (very much). Higher scores correspond to a better quality of life.

  Assessment will be conducted at baseline and at 6 months to assess change from baseline

• Changes in Quality of life (QoL)

  QoL will be measured through the European Quality of Life Scale (EQ-5D-3L; EQ-5D User Guides, 2021). The EQ-5D-3L consists of 2 pages: the EQ5D descriptive system and the EQ visual analogue scale (EQ VAS). The EQ-5D-3L descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale of 100 points where the endpoints are labelled 'Best imaginable health state' and 'Worst imaginable health state'.

  Assessment will be conducted at baseline and at 3 months, 6 months and 9 months to assess change from baseline

• Changes in Symptom control

  Symptom management will be measured through the Edmonton Symptom Assessment System (ESAS-r; Carvajal et al., 2012). ESAS-r is an instrument that is commonly used both in PC and in advanced cancer situations. It has 10 visual numerical scales that assess physical and psychological symptoms. Patients choose the number that best represents the intensity of each symptom on a scale of 0 to 10.

  Assessment will be conducted at 3 months and at 9 months to assess change

• Changes in Medication adherence

  Medication adherence will be measured through the Simplified Medication Adherence Questionnaire (ARMS-e; Kripalani et al., 2009). The ARMS-e assesses medication adherence in patients with chronic conditions in 12 self-reported items with 4 response possibilities: never, sometimes, most of the time and always. Lower overall scores correspond to better adherence.

  Assessment will be conducted at baseline and at 3 months, 6 months and 9 months to assess change from baseline

Secondary Outcomes (3)

• Platform satisfaction

  Assessment will be conducted 3 months from baseline

• Platform usability

  Assessment will be conducted 6 months from baseline

• Changes in Emotional wellbeing

  Every 15 days during the 9 months to assess change

Study Arms (2)

eHealth ecosystem of stepped psychosocial care

EXPERIMENTAL

Patients will be monitored allowing the delivery of timely and personalized care via a 4-level program: 1. Screening and psychosocial monitoring through a mobile application where patients have a messaging system to contact their psychologist and reference nurse. 2. Psychoeducation and health education campus, where patients can consult videos and online resources developed by health professionals, containing scientifically validated information. 3. Psychosocial support community where patients can share doubts, fears, and experiences with other patients with advanced lung cancer. This private social network is monitored by team specialists when necessary. 4. Online group psychotherapy of 8 weekly sessions of 90 minutes based on Meaning-Centered Group Psychotherapy (MCGP; Breitbart et al., 2010). Patients at this level will be on a waiting list, so the pool starts when there are 4-8 users available.

Behavioral: E-health ecosystem of stepped psychosocial care

Usual psychosocial care

ACTIVE COMPARATOR

This group will receive standard psychosocial care for cancer survivors at ICO Hospitalet center led by a clinical psychologist. It consists of 7 individual sessions of 45-60 minutes, scheduled every 2-3 weeks during 9 months and focused on emotional support and psychoeducation. Moreover, they will be offered the education materials from the 2nd step of the platform, as they are compiled in a website open to all patients and relatives.

Behavioral: Usual psychosocial care

Interventions

E-health ecosystem of stepped psychosocial care BEHAVIORAL

1. Screening and monitoring: weekly administration of an emotional state thermometer. If the score is \>5, participants are asked to complete the HADS. If HADS' score \>10, step 2 is assigned. The same procedure is followed for steps 3 \& 4. Participants remain in each step for 2 weeks, and all level changes are preceded by a videoconference with a health professional 2. Online psychoeducation campus: displays co-constructed videos and posts developed by health professionals and patients about LC diagnosis and treatment aspects. 3. Online support community: anonymous survivors with LC diagnoses are included. Professionals and patient mentors supervise and foster debate, peer support, and resolve health Q\&As. 4. Weekly online group psychotherapy led by a clinical psychologist and composed of eight 90-minute sessions. Eligible users are placed on a waiting list, starting when 5-6 users are available.

Also known as: ICOnnecta't

eHealth ecosystem of stepped psychosocial care

Usual psychosocial care BEHAVIORAL

Usual psychosocial care for cancer survivors at ICOHospitalet centre led by a clinical psychologist. Usual psychosocial care consists of 7 individual sessions of 45-60 minutes, with 2-3 weeks of space between sessions, based on Individual Meaning-Centered Psychotherapy (IMCP) for Patients With Advanced Cancer (Breitbart et al., 2012). Moreover, they will be offered the education materials from the 2nd step of the platform, as they are compiled on a website open to all patients and relatives.

Usual psychosocial care

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Being adult (≥18 years)
• LC diagnosis in advanced stages -III-IV
• Access to internet and user-level experience
• Reading and writing skills in Spanish

You may not qualify if:

• Current major depressive episode
• Risk of self-harm
• Active psychotic symptoms
• Substance abuse

Sponsors & Collaborators

• Institut Català d'Oncologia: lead
• Asociación Española contra el Cáncer: collaborator
• Institut d'Investigació Biomèdica de Bellvitge: collaborator

Study Sites (1)

Institut Català d'Oncologia

L'Hospitalet de Llobregat, Catalonia, 08908, Spain

RECRUITING

Related Publications (22)

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• Sepulveda C, Marlin A, Yoshida T, Ullrich A. Palliative Care: the World Health Organization's global perspective. J Pain Symptom Manage. 2002 Aug;24(2):91-6. doi: 10.1016/s0885-3924(02)00440-2. No abstract available.

  PMID: 12231124 BACKGROUND

• Lobb EA, Lacey J, Kearsley J, Liauw W, White L, Hosie A. Living with advanced cancer and an uncertain disease trajectory: an emerging patient population in palliative care? BMJ Support Palliat Care. 2015 Dec;5(4):352-7. doi: 10.1136/bmjspcare-2012-000381. Epub 2013 Jan 28.

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• Fulton JJ, LeBlanc TW, Cutson TM, Porter Starr KN, Kamal A, Ramos K, Freiermuth CE, McDuffie JR, Kosinski A, Adam S, Nagi A, Williams JW. Integrated outpatient palliative care for patients with advanced cancer: A systematic review and meta-analysis. Palliat Med. 2019 Feb;33(2):123-134. doi: 10.1177/0269216318812633. Epub 2018 Nov 29.

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• Travado L, Reis JC, Watson M, Borras J. Psychosocial oncology care resources in Europe: a study under the European Partnership for Action Against Cancer (EPAAC). Psychooncology. 2017 Apr;26(4):523-530. doi: 10.1002/pon.4044. Epub 2015 Dec 21.

  PMID: 26685870 BACKGROUND

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• Spiegel D. Mind matters in cancer survival. Psychooncology. 2012 Jun;21(6):588-93. doi: 10.1002/pon.3067. Epub 2012 Mar 21.

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• Bekelman DB, Rabin BA, Nowels CT, Sahay A, Heidenreich PA, Fischer SM, Main DS. Barriers and Facilitators to Scaling Up Outpatient Palliative Care. J Palliat Med. 2016 Apr;19(4):456-9. doi: 10.1089/jpm.2015.0280. Epub 2016 Mar 14.

  PMID: 26974489 BACKGROUND

• Berry DL, Blumenstein BA, Halpenny B, Wolpin S, Fann JR, Austin-Seymour M, Bush N, Karras BT, Lober WB, McCorkle R. Enhancing patient-provider communication with the electronic self-report assessment for cancer: a randomized trial. J Clin Oncol. 2011 Mar 10;29(8):1029-35. doi: 10.1200/JCO.2010.30.3909. Epub 2011 Jan 31.

  PMID: 21282548 BACKGROUND

• Escriva Boulley G, Leroy T, Bernetiere C, Paquienseguy F, Desfriches-Doria O, Preau M. Digital health interventions to help living with cancer: A systematic review of participants' engagement and psychosocial effects. Psychooncology. 2018 Dec;27(12):2677-2686. doi: 10.1002/pon.4867. Epub 2018 Sep 24.

  PMID: 30152074 BACKGROUND

• Ochoa-Arnedo C, Flix-Valle A, Casellas-Grau A, Casanovas-Aljaro N, Herrero O, Sumalla EC, de Frutos ML, Sirgo A, Rodriguez A, Campos G, Valverde Y, Travier N, Medina JC. An exploratory study in breast cancer of factors involved in the use and communication with health professionals of Internet information. Support Care Cancer. 2020 Oct;28(10):4989-4996. doi: 10.1007/s00520-020-05335-x. Epub 2020 Feb 7.

  PMID: 32034515 BACKGROUND

• Vaganian L, Bussmann S, Gerlach AL, Kusch M, Labouvie H, Cwik JC. Critical consideration of assessment methods for clinically significant changes of mental distress after psycho-oncological interventions. Int J Methods Psychiatr Res. 2020 Jun;29(2):e1821. doi: 10.1002/mpr.1821. Epub 2020 Feb 23.

  PMID: 32090408 BACKGROUND

• Harju E, Michel G, Roser K. A systematic review on the use of the emotion thermometer in individuals diagnosed with cancer. Psychooncology. 2019 Sep;28(9):1803-1818. doi: 10.1002/pon.5172. Epub 2019 Jul 23.

  PMID: 31291692 BACKGROUND

• Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.

  PMID: 6880820 BACKGROUND

• Kripalani S, Risser J, Gatti ME, Jacobson TA. Development and evaluation of the Adherence to Refills and Medications Scale (ARMS) among low-literacy patients with chronic disease. Value Health. 2009 Jan-Feb;12(1):118-23. doi: 10.1111/j.1524-4733.2008.00400.x.

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• R Core Team. R: A Language and Environment for Statistical Computing. Published online 2020.

  BACKGROUND

• Peterman AH, Fitchett G, Brady MJ, Hernandez L, Cella D. Measuring spiritual well-being in people with cancer: the functional assessment of chronic illness therapy--Spiritual Well-being Scale (FACIT-Sp). Ann Behav Med. 2002 Winter;24(1):49-58. doi: 10.1207/S15324796ABM2401_06.

  PMID: 12008794 BACKGROUND

• Kissane DW, Wein S, Love A, Lee XQ, Kee PL, Clarke DM. The Demoralization Scale: a report of its development and preliminary validation. J Palliat Care. 2004 Winter;20(4):269-76.

  PMID: 15690829 BACKGROUND

• Cella DF, Bonomi AE, Lloyd SR, Tulsky DS, Kaplan E, Bonomi P. Reliability and validity of the Functional Assessment of Cancer Therapy-Lung (FACT-L) quality of life instrument. Lung Cancer. 1995 Jun;12(3):199-220. doi: 10.1016/0169-5002(95)00450-f.

  PMID: 7655830 BACKGROUND

• Carvajal A, Hribernik N, Duarte E, Sanz-Rubiales A, Centeno C. The Spanish version of the Edmonton Symptom Assessment System-revised (ESAS-r): first psychometric analysis involving patients with advanced cancer. J Pain Symptom Manage. 2013 Jan;45(1):129-36. doi: 10.1016/j.jpainsymman.2012.01.014. Epub 2012 Aug 25.

  PMID: 22926088 BACKGROUND

• Breitbart W, Poppito S, Rosenfeld B, Vickers AJ, Li Y, Abbey J, Olden M, Pessin H, Lichtenthal W, Sjoberg D, Cassileth BR. Pilot randomized controlled trial of individual meaning-centered psychotherapy for patients with advanced cancer. J Clin Oncol. 2012 Apr 20;30(12):1304-9. doi: 10.1200/JCO.2011.36.2517. Epub 2012 Feb 27.

  PMID: 22370330 BACKGROUND

• Ochoa-Arnedo C, Arizu-Onassis A, Medina JC, Flix-Valle A, Ciria-Suarez L, Gomez-Fernandez D, Souto-Sampera A, Brao I, Palmero R, Nadal E, Gonzalez-Barboteo J, Serra-Blasco M. An eHealth ecosystem for stepped and early psychosocial care in advanced lung cancer: Rationale and protocol for a randomized control trial. Internet Interv. 2023 Apr 3;32:100620. doi: 10.1016/j.invent.2023.100620. eCollection 2023 Apr.

  PMID: 37273934 DERIVED

Related Links

• EQ-5D User Guides -EQ-5D. Accessed March 29, 2021.
• IBM SPSS Statistics 21 -España. Accessed October 5, 2017.

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Lung Neoplasms; Patient Participation; Behavior

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior

Study Officials

• Cristian Ochoa, PhD

  Institut Català d'Oncologia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria Serra Blasco, PhD

CONTACT

+34 932607800; mariaserrab@iconcologia.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Non-inferiority randomized trial testing two experimental conditions: 1) ehealth ecosystem, 2) usual psychosocial care. Assessment of main outcomes are conducted at recruitment (T0), 3 months from T0 (T1), 6 months from T0 (T2), and 9 months from T0 (T3). Hence, the design is 2 (treatment conditions) X 4 (assessments). The whole project's methodology adheres to the principles of Responsible Research and Innovation (RRI). The sample size has been estimated with the support of the R software (R Core Team, 2020), setting a non-inferiority margin of 5 points in the Hospital Anxiety and Depression Scale (Vaganian et al., 2020), with power at 80% and one-tailed α of 2.5%. A dropout rate of 25% was assumed. It was anticipated that 152 participants were necessary (n = 76 per arm) to ensure that a two-sided 95% confidence interval would exclude the non-inferiority threshold.

Study Record Dates

• First Submitted: August 2, 2022
• First Posted: August 11, 2022
• Study Start: November 15, 2022
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: September 29, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)