The "Hand-in-Hand Study": Improvement of Quality of Life in Palliative Cancer Patients Through Collaborative Advance Care Planning

NCT03387436 | Unknown

• 1 other identifier: 01GY1708
• Study Type: interventional
• Target: 280
• Locations: 1 country
• Sites: 2

Brief Summary

This study evaluates the effect of a collaborative advance care planning intervention on the quality of life in palliative oncological patients. Research indicates, that talking about wishes for end of life care and death, may improve the quality of life, but can be difficult for involved parties. The intervention especially developed for this study trys to reduce psychosocial barriers that make conversations about these topics difficult. The study will measure the effect of the intervention on patients and caregivers quality of life. The study will give additional information about implementation of advance care planning interventions in different care settings in a complex health care systems.

Conditions

Advanced Cancer; Neoplasms; End Stage Cancer

Keywords

Palliative care; Advance care planning; psychological intervention

Outcome Measures

Primary Outcomes (1)

• The Functional Assessment of Cancer Therapy scale (FACT-G; Cella, Tulsky, Gray, et al., 1993)

  Quality of life (QOL). Self-rating measurement; four subscales: physical well-being (7-items, score range 0-28), social/ family well-being (7-items, score range 0-28), emotional well being (6-items, score range 0-24) and functional well being (7-items, score range 0-28), one total score (sum of the four subscale scores; score range of 0-108). Higher subscale and total scores indicate better QoL.

  60 weeks; Baseline, 8 weeks (after randomisation: a.r.), 16 weeks (a. r.); every two month for the following 8 month or till death (if occuring within one year after randomisation)

Secondary Outcomes (16)

• 12-Item Short Form Health Survey (SF-12; Ware, Kosinski, Keller, 1996)

  60 weeks; Baseline, 8 weeks (after randomisation: a.r.), 16 weeks (a. r.); every two month for the following 8 month or till death (if occuring within one year after randomisation)

• Functional assessment of chronic illness therapy - palliative care- 14 items (FACIT-Pal-14; Zeng et al. 2014)

  60 weeks; Baseline, 8 weeks (after randomisation: a.r.), 16 weeks (a. r.); every two month for the following 8 months or till death (if occuring one year after randomisation)

• National Comprehensive Cancer Network Distress Thermometer (Mehnert et al. 2006)

  16 weeks; Baseline, 8 weeks (after randomisation: a.r.), 16 weeks (a. r.)

• Peace, Equanimity, and Acceptance in the Cancer Experience (PEACE-Scale, Mack et al. 2008)

  16 weeks; Baseline, 8 weeks (after randomisation: a.r.), 16 weeks (a. r.)

• Barriers of communication (patients)

  8 weeks; Baseline, 8 weeks (after randomisation: a.r.)

Study Arms (3)

1.) Treatment as usual (TAU)

NO INTERVENTION

Patients assigned to this arm will receive palliative treatment as usual.

2.) Sham-Intervention

SHAM COMPARATOR

Patients assigned to this arm will receive an sham intervention with unspecific supportive therapy (i.e. listening, empathy etc., but no specific intervention rationale) and palliative treatment as usual.

Behavioral: Sham-Intervention

3.) Study-Intervention

EXPERIMENTAL

Patients assigned to this arm will receive the study-intervention and palliative treatment as usual.

Behavioral: Study-Intervention

Interventions

Sham-Intervention BEHAVIORAL

The sham intervention does not target the specific topics of the study intervention group (i.e. no special focus an ACP or end of life communication). Supportive therapy uses common factors of psychotherapy such as elicitation of affect, reflective listening, and feeling understood, but provides no explicit theoretical formulation to the patient. The therapist tries to elicit and validate the patients' affect for instance on the realization that there is no curative treatment option. Supportive therapy has been used as an unspecific control condition in several studies (Cohen et al. 2011; Markowitz et al. 1998). Patients of the sham intervention will be informed about the benefits of advance directives in general.

2.) Sham-Intervention

Study-Intervention BEHAVIORAL

The design of the study-intervention was influenced by dignity therapy (Chochinov et al. 2005), the End-of-life-Review (Ando et al. 2010) and barriers concerning participation of ACP identified by research (Bollig et al. 2017; Gjerberg et al. 2015). It is the goal of the study-intervention to enhance communication about death related topics of patients and their relatives/caregivers. Our study intervention extends over six therapeutic sessions. The length of each session will be adjusted to the patients physical condition, it should not exceed 45 minutes in total. In the first four sessions, patients and relatives will be informed about the relevance of ACP. Potential barriers for an efficient patient-caregiver communication and ACP are discussed. The intervention focuses on encouraging end-of-life communication and on jointly modifying barriers to EOL communication. The fifth and sixth session focus on ACP based on the standardised concept of "beizeiten begleiten".

3.) Study-Intervention

Eligibility Criteria

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

You may qualify if:

• Patient \> 18 years
• Patient with advance cancer in palliative setting
• positive surprise question: the physician will not be surprised, if the patient died in the next 12 month
• Patient is willing to take part in the study

You may not qualify if:

• Patients life expectancy below 3 month (estimated by physician)
• Patients ECOG-status is \> 3
• Patient is not able to speak German
• Patient is incapacitated to give informed consent

Sponsors & Collaborators

• PD. Dr. med. Carola Seifart: lead
• Philipps University Marburg: collaborator
• German Federal Ministry of Education and Research: collaborator
• Department of Clinical Psychology and Psychotherapy: collaborator

Study Sites (2)

Philipps University, Departement of Psychology, Division of Clinical Psychology and Psychtherapy

Marburg, 35037, Germany

ENROLLING BY INVITATION

Philipps University

Marburg, 35043, Germany

RECRUITING

Related Publications (19)

• Ando M, Morita T, Akechi T, Okamoto T; Japanese Task Force for Spiritual Care. Efficacy of short-term life-review interviews on the spiritual well-being of terminally ill cancer patients. J Pain Symptom Manage. 2010 Jun;39(6):993-1002. doi: 10.1016/j.jpainsymman.2009.11.320.

  PMID: 20538183 BACKGROUND

• Chochinov HM, Hack T, Hassard T, Kristjanson LJ, McClement S, Harlos M. Dignity therapy: a novel psychotherapeutic intervention for patients near the end of life. J Clin Oncol. 2005 Aug 20;23(24):5520-5. doi: 10.1200/JCO.2005.08.391.

  PMID: 16110012 BACKGROUND

• Bollig G, Rosland JH, Gjengedal E, Schmidt G, May AT, Heller A. A European multicenter study on systematic ethics work in nursing homes. Scand J Caring Sci. 2017 Sep;31(3):587-601. doi: 10.1111/scs.12373. Epub 2016 Aug 26.

  PMID: 27561245 BACKGROUND

• Weitzner MA, Jacobsen PB, Wagner H Jr, Friedland J, Cox C. The Caregiver Quality of Life Index-Cancer (CQOLC) scale: development and validation of an instrument to measure quality of life of the family caregiver of patients with cancer. Qual Life Res. 1999;8(1-2):55-63. doi: 10.1023/a:1026407010614.

  PMID: 10457738 BACKGROUND

• Weitzner MA, McMillan SC. The Caregiver Quality of Life Index-Cancer (CQOLC) Scale: revalidation in a home hospice setting. J Palliat Care. 1999 Summer;15(2):13-20.

  PMID: 10425873 BACKGROUND

• Cohen L, Parker PA, Vence L, Savary C, Kentor D, Pettaway C, Babaian R, Pisters L, Miles B, Wei Q, Wiltz L, Patel T, Radvanyi L. Presurgical stress management improves postoperative immune function in men with prostate cancer undergoing radical prostatectomy. Psychosom Med. 2011 Apr;73(3):218-25. doi: 10.1097/PSY.0b013e31820a1c26. Epub 2011 Jan 21.

  PMID: 21257977 BACKGROUND

• Markowitz JC, Kocsis JH, Fishman B, Spielman LA, Jacobsberg LB, Frances AJ, Klerman GL, Perry SW. Treatment of depressive symptoms in human immunodeficiency virus-positive patients. Arch Gen Psychiatry. 1998 May;55(5):452-7. doi: 10.1001/archpsyc.55.5.452.

  PMID: 9596048 BACKGROUND

• Mack JW, Nilsson M, Balboni T, Friedlander RJ, Block SD, Trice E, Prigerson HG. Peace, Equanimity, and Acceptance in the Cancer Experience (PEACE): validation of a scale to assess acceptance and struggle with terminal illness. Cancer. 2008 Jun;112(11):2509-17. doi: 10.1002/cncr.23476.

  PMID: 18429006 BACKGROUND

• Zeng L, Bedard G, Cella D, Thavarajah N, Chen E, Zhang L, Bennett M, Peckham K, De Costa S, Beaumont JL, Tsao M, Danjoux C, Barnes E, Sahgal A, Chow E. Preliminary results of the generation of a shortened quality-of-life assessment for patients with advanced cancer: the FACIT-Pal-14. J Palliat Med. 2013 May;16(5):509-15. doi: 10.1089/jpm.2012.0595. Epub 2013 Apr 16.

  PMID: 23590181 BACKGROUND

• Miller DC, Sanda MG, Dunn RL, Montie JE, Pimentel H, Sandler HM, McLaughlin WP, Wei JT. Long-term outcomes among localized prostate cancer survivors: health-related quality-of-life changes after radical prostatectomy, external radiation, and brachytherapy. J Clin Oncol. 2005 Apr 20;23(12):2772-80. doi: 10.1200/JCO.2005.07.116.

  PMID: 15837992 BACKGROUND

• Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.

  PMID: 11556941 BACKGROUND

• Heckel M, Bussmann S, Stiel S, Weber M, Ostgathe C. Validation of the German Version of the Quality of Dying and Death Questionnaire for Informal Caregivers (QODD-D-Ang). J Pain Symptom Manage. 2015 Sep;50(3):402-13. doi: 10.1016/j.jpainsymman.2015.03.020. Epub 2015 Jun 14.

  PMID: 26079825 BACKGROUND

• Prigerson HG, Maciejewski PK, Reynolds CF 3rd, Bierhals AJ, Newsom JT, Fasiczka A, Frank E, Doman J, Miller M. Inventory of Complicated Grief: a scale to measure maladaptive symptoms of loss. Psychiatry Res. 1995 Nov 29;59(1-2):65-79. doi: 10.1016/0165-1781(95)02757-2.

  PMID: 8771222 BACKGROUND

• Cella DF, Tulsky DS, Gray G, Sarafian B, Linn E, Bonomi A, Silberman M, Yellen SB, Winicour P, Brannon J, et al. The Functional Assessment of Cancer Therapy scale: development and validation of the general measure. J Clin Oncol. 1993 Mar;11(3):570-9. doi: 10.1200/JCO.1993.11.3.570.

  PMID: 8445433 BACKGROUND

• Mehnert, Anja; Müller, Diana; Lehmann, Claudia; Koch, Uwe (2006): Die deutsche Version des NCCN Distress-Thermometers. In: Zeitschrift für Psychiatrie, Psychologie und Psychotherapie 54 (3), S. 213-223. DOI: 10.1024/1661-4747.54.3.213.

  BACKGROUND

• Ware J Jr, Kosinski M, Keller SD. A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. Med Care. 1996 Mar;34(3):220-33. doi: 10.1097/00005650-199603000-00003.

  PMID: 8628042 BACKGROUND

• Lumbeck, Gudrun; Brandstätter, Monika; Geissner, Edgar (2012): Erstvalidierung der deutschen Version des "Inventory of Complicated Grief" (ICG-D). In: Zeitschrift für Klinische Psychologie und Psychotherapie 41 (4), p. 243-248.

  BACKGROUND

• Seifart C, Koch M, Herzog S, Leppin N, Nagelschmidt K, Riera Knorrenschild J, Timmesfeld N, Denz R, Seifart U, Rief W, Von Blanckenburg P. Collaborative advance care planning in palliative care: a randomised controlled trial. BMJ Support Palliat Care. 2024 Jul 2:spcare-2023-004175. doi: 10.1136/spcare-2023-004175. Online ahead of print.

  PMID: 38960600 DERIVED

• Seifart C, Koch M, Leppin N, Nagelschmidt K, Knorrenschild JR, Timmesfeld N, Rief W, von Blanckenburg P. Collaborative advance care planning in advanced cancer patients: col-ACP -study - study protocol of a randomised controlled trial. BMC Palliat Care. 2020 Aug 24;19(1):134. doi: 10.1186/s12904-020-00629-7.

  PMID: 32838763 DERIVED

MeSH Terms

Conditions

Neoplasms

Study Officials

• Carola Seifart, PD Dr. med

  Philipps University Marburg

  PRINCIPAL INVESTIGATOR

• Pia von Blanckenburg, Phd.

  Philipps University Marburg, Department of Psychology, Division of Clinical Psychology and Psychotherapy

  STUDY DIRECTOR

Central Study Contacts

Carola Seifart, PD Dr. med.

CONTACT

0049/6421/5866156; carola.seifart@staff.uni-marburg.de

Pia von Blanckenburg, Ph. D

CONTACT

0049/6421/2824051; pia.vonblanckenburg@staff.uni-marburg.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: As in most psychological interventions, care providers (psychologists) can not be blinded, because they are delivering the intervention. Patients only know if they are in one of the intervention groups or in TAU. All other study personnel will be blinded.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor-Investigator

Model Details: Participants will be allocated randomly to three arms: 1. palliative treatment as usual (TAU) 2. sham-intervention + (TAU) 3. study-intervention + (TAU) Stratification will be carried out for sex, and availability of a care giver.

Study Record Dates

• First Submitted: December 4, 2017
• First Posted: January 2, 2018
• Study Start: December 4, 2017
• Primary Completion: January 1, 2020
• Study Completion: September 1, 2020
• Last Updated: June 20, 2019

Record last verified: 2019-06

Locations

DE (2)