Online Psychosocial Cancer Screening, Monitoring and Stepped Treatment in Cancer Survivors

NCT04372459 | Completed

• 2 other identifiers: ICOnnectat-BCPI19/01880
• Study Type: interventional
• Target: 184
• Locations: 1 country
• Sites: 1

Brief Summary

This multicenter randomized controlled study will appraise the effectiveness and cost-utility of an e-health ecosystem with integrated and stepped psychosocial services that will be compared with the usual psychosocial care. The study is developed in the acute survival phase among breast cancer survivors. The outcomes of both interventions will be compared in terms of the amount of waiting time to receive psychosocial care and changes in several psychosocial variables. Finally, a comparative economic analysis will be conducted in other relevant psychosocial and health parameters. The e-health platform is expected to outperform usual care in the aforementioned indicators, while reaching high acceptability and usability by survivors, and additionally reducing costs for health providers.

Conditions

Breast Cancer; Psychological Distress; Emotional Disorder

Keywords

e-health; breast cancer; survivors; psychosocial care; distress; Randomised Controlled Trial

Outcome Measures

Primary Outcomes (5)

• Change in Emotional Distress (HADS)

  Hospital Anxiety and Depression Scale (HADS) (Zigmond \& Snaith, 1983; Spanish validation by Costa-Requena, Pérez Martín, Salamero Baró, \& Gil Moncayo, 2009). It consists of 14 items, 7 for anxiety and 7 for depression, on a four-point Likert scale (range 0-3), with the total score ranging from 0 to 42. Higher scores indicate a greater level of distress.

  Time 1: Baseline; Time 2: Change between Time 1 and 3 months post-intervention; Time 3: Change between Time 1 and 6 months post-intervention; Time 4: Change between Time 1 and 12 months post-intervention

• Change in Post-traumatic Stress (PCL-5)

  Post-traumatic Stress Disorder Checklist-Civilian version (PCL-5) (Blevins, Weathers, Davis, Witte, \& Domino, 2015). The official Spanish translation of the instrument was provided by the National Center for Post-Traumatic Stress Disorder (www.ptsd.va.gov/). The PCL-5 is a 20-item questionnaire, corresponding to the "Diagnostic and Statistical Manual for Mental Disorders Version 5" symptom criteria for PTSD. The self-report rating scale is 0-4 for each symptom, reflecting a change from 1-5 in the DSM-IV version. Rating scale descriptors are the same: "Not at all," "A little bit," Moderately," "Quite a bit," and "Extremely." A total symptom severity score (range - 0-80) can be obtained by summing the scores for each of the 20 items, with higher scores indicating worse outcomes.

  Time 1: Baseline; Time 2: Change between Time 1 and 3 months post-intervention; Time 3: Change between Time 1 and 6 months post-intervention; Time 4: Change between Time 1 and 12 months post-intervention

• Change in Post-traumatic Growth (PTGI)

  Post-traumatic Growth Inventory (PTGI) (Tedeschi \& Calhoun, 1996; Spanish validation by Costa-Requena and Gil, 2007). It is a 21-item instrument based on a 6-point Likert scale (0=no change - 5=very high degree of change), which assesses positive changes experienced after a trauma. Total scores range from 0 to 105 with higher scores indicating better outcomes.

  Time 1: Baseline; Time 2: Change between Time 1 and 3 months post-intervention; Time 3: Change between Time 1 and 6 months post-intervention; Time 4: Change between Time 1 and 12 months post-intervention

• Change in Therapeutic alliance (WAI-P)

  Working Alliance Inventory-Patient Version (WAI-P; Horvath, 1981; Horvath \& Greenberg, 1986, 1989; Spanish validation by Andrade-González \& Fernández-Liria, 2015). It consists of 36 items with seven possible response options (1 = never, 2 = rarely, 3 = occasionally, 4 = sometimes, 5 = often, 6 = very often, 7 = always). The scoring range of the overall WAI-P is 36-252 points with higher scores indicating better outcomes.

  Time 2: Change between Time 1 and 3 months post-intervention; Time 3: Change between Time 1 and 6 months post-intervention; Time 4: Change between Time 1 and 12 months post-intervention

• Change in Quality of Life (EQ-5D-3L)

  EuroQoL-EQ-5D-3L (EuroQol Group, 1990; Spanish validation by Abadia et al., 1999). It consists of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. Total scores range from 0-100 with higher scores indicating better outcomes.

  Time 1: Baseline; Time 2: Change between Time 1 and 3 months post-intervention; Time 3: Change between Time 1 and 6 months post-intervention; Time 4: Change between Time 1 and 12 months post-intervention

Secondary Outcomes (6)

• Healthcare utilization

  Time 4: 12 months post-intervention

• Change in Medication use and adherence (ARMS)

  Time 1: Baseline; Time 2: Change between Time 1 and 3 months post-intervention; Time 3: Change between Time 1 and 6 months post-intervention; Time 4: Change between Time 1 and 12 months post-intervention

• Work absenteeism

  Time 4: 12 months post-intervention

• Professionals' salaries

  Time 4: 12 months post-intervention

• Infrastructure costs

  Time 4: 12 months post-intervention

Other Outcomes (4)

• Emotional wellbeing (experimental group only)

  Administration every 7 days until the end of treatment (or study completion), an average of 1 year

• Health education

  Single administration per educational topic (7 thematic blocks, 16 topics, 40 questionnaires) until the end of treatment (or study completion), an average of 1 year

• Usability (experimental group only) (SUS)

  21 days after registration

Study Arms (2)

Online integrated and stepped psychosocial care

EXPERIMENTAL

A group of breast cancer survivors will be randomly allocated (1:1 allocation) to the online integrated and stepped psychosocial care group

Behavioral: Online integrated and stepped psychosocial care

Usual psychosocial care

EXPERIMENTAL

A group of breast cancer survivors will be randomly allocated (1:1 allocation) to the usual psychosocial care group

Behavioral: Usual psychosocial care

Interventions

Online integrated and stepped psychosocial care BEHAVIORAL

This program features four levels of care, increasing in intensity of psychosocial care as patients move from one level to the next one. Step 1: Screening and monitoring of several psychosocial variables through the central mobile application of the program (App ICOnnecta't). Step 2: Online guided and self-help psychoeducation Campus in which patients can consult videos and online resources, co-constructed between health professionals and patients, containing reliable and rigorous information related to the oncological process. Step 3: Online community of psychosocial support. Participants can choose from 12 cancer-related discussion forums and share with the community any health-related question that worries them fostering, thus, debate and stimulating peer-support. Step 4: Intensive online group psychotherapy (App ICOnnecta't Videoconsultation), based on the Group Positive Psychotherapy program for cancer survivors (Ochoa, Sumalla, Maté, Castejón, Rodríguez et al., 2010).

Online integrated and stepped psychosocial care

Usual psychosocial care BEHAVIORAL

This active control group will receive the standard psychosocial treatment for cancer survivors in the participating centers, led by a clinical psychologist and consisting of 8 individual, 45/60-minute sessions, each of which every 1-2 months, focused on providing emotional support and psychoeducation during the first year of primary cancer treatment.

Usual psychosocial care

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged between 18 and 70 years with BC, within 6 weeks after diagnosis.
• Having online access and a user-level knowledge of Internet.
• Understanding of Spanish language.

You may not qualify if:

• Major depressive episode.
• Significant autolytic ideation.
• Showing symptoms of psychosis or substance abuse.
• Intellectual disability.
• Having a mobile phone with an old release of Android operating system, which is not compatible with the platform.

Sponsors & Collaborators

• Institut Català d'Oncologia: lead

Study Sites (1)

Institut Català d'Oncologia L'Hospitalet

L'Hospitalet de Llobregat, Barcelona, 08908, Spain

Location

Related Publications (1)

• Ochoa-Arnedo C, Medina JC, Flix-Valle A, Anastasiadou D. E-health ecosystem with integrated and stepped psychosocial services for breast cancer survivors: study protocol of a multicentre randomised controlled trial. BMJ Open. 2021 Mar 8;11(3):e041548. doi: 10.1136/bmjopen-2020-041548.

  PMID: 34006024 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Cristian Ochoa, PhD

  Institut Català d'Oncologia, L'Hospitalet de Llobregat, Barcelona, Spain, 08908

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, Clinical Psychologist

Model Details: The current clinical trial is a multicenter Randomised Controlled Trial with 2 parallel groups. The effectiveness of the online integrated and stepped psychosocial care group will be compared with the usual psychosocial care group

Study Record Dates

• First Submitted: April 24, 2020
• First Posted: May 4, 2020
• Study Start: June 21, 2021
• Primary Completion: July 30, 2023
• Study Completion: July 30, 2023
• Last Updated: March 6, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: January 2023-January 2033
• Access Criteria: Access will be granted through formal requests from interested researchers. In order to keep control on data access we will register contact details of these scientists and their objectives for data use.

Locations

ES (1)