Efficacy of a Dyadic Cancer-related Communication Reinforcement Intervention

NCT03723122 | Completed

• 1 other identifier: DCRI
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

Background: To face cancer-related stress, patients and caregivers activate individual and dyadic coping responses. Opened communication, adequate involvement, reciprocal supportive roles, self-disclosure and responsiveness enhance dyadic coping. Nevertheless, little is known about the optimal content of dyadic interventions designed to improve dyadic communication. Methods: A randomized controlled trail was designed to assess the efficacy of a dyadic intervention centered on a cancer-related communication reinforcement. Patient-caregiver dyads are randomly assigned to either an intervention group or a waiting list group. Patients and caregivers complete self-reported scales that assessed emotional distress, individual coping, cancer-related dyadic communication frequency, satisfaction, self-efficacy and coping at baseline and post-treatment (intervention group), or 6 weeks after baseline (waiting list group). This dyadic communication reinforcement intervention (DCRI) consists of a weekly 4-session intervention. This intervention includes specific communication tasks aiming the improvement of some cancer-related dyadic communication competencies such as concerns disclosure and request for support. Discussion: DCRI would lead to improvements in cancer-related dyadic communication self-efficacy, cancer-related dyadic communication satisfaction and dyadic coping.

Conditions

Cancer; Communication Programs

Keywords

Psychological intervention; Dyadic communication; Dyadic adaptation to cancer

Outcome Measures

Primary Outcomes (2)

• Cancer-related dyadic communication

  Cancer-related dyadic communication self-efficacy through a self-reported scale for patients and caregivers. The perceived dyadic communication self-efficacy was measured by a 6-dimension scale: Dyadic Communication Competencies. Each dimension is divided into 5 items. Subject has to rate each item on a 0-100 range (0 = not certain; 100 = absolutely certain) to report how he is certain to matser the communication competency. A total score (ranging 0-100) for each dimension is computed by making the mean of all item scores. A higher score reflects a higher perceived communication self-efficacy.

  2 months

• Dyadic coping

  Cancer-related dyadic coping through a validated self-reported scale for patients and caregivers: Dyadic Coping Inventory (DCI). It is composed of the following six different dimensions: stress communication, supportive dyadic coping, delegated dyadic coping, negative dyadic coping, common dyadic coping and evaluation of dyadic coping. The DCI has a 5-point Likert scale (1 = "Rarely"; 5 = "Very Frequently") and provides a total score (35-175) by summing all items. A higher score reflects a better dyadic coping.

  2 months

Secondary Outcomes (1)

• Emotional Distress

  2 months

Study Arms (2)

DCRI program

EXPERIMENTAL

Patient-caregiver dyads will immediately attend the Dyadic communication reinforcement intervention. For both groups, first assessment time take place just after the enrollment, before the randomization. For this group, second assessment time take place 2 weeks post-intervention. Pre-post assessments consist in self-reported scales assessing emotional distress, individual coping, cancer-related dyadic communication frequency, satisfaction, self-efficacy and coping.

Behavioral: Dyadic Communication Reinforcement Intervention

Waiting List

NO INTERVENTION

Patient-caregiver dyads are in a waiting condition for 6 weeks. They will attend the Intervention after the second assessment time if they want to. For both group, first assessment time take place just after the enrollment, before the randomization. For this group, second assessment time take place 6 weeks after first assessment time. First and second assessment consist in self-reported scales assessing emotional distress, individual coping, cancer-related dyadic communication frequency, satisfaction, self-efficacy and coping.

Interventions

Dyadic Communication Reinforcement Intervention BEHAVIORAL

Psycho-educative and behavioral intervention centered on cancer-related dyadic communication

DCRI program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• To read and speak French
• To be aged 18 years old or more

You may not qualify if:

• Not be treated for a psychiatric disorder

Sponsors & Collaborators

• Université Libre de Bruxelles: lead

Study Sites (1)

Hopital Erasme & Institut Jules Bordet

Brussels, 1000, Belgium

Location

Related Publications (14)

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  BACKGROUND

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  BACKGROUND

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  PMID: 21678368 BACKGROUND

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  PMID: 24100089 BACKGROUND

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  PMID: 27039207 BACKGROUND

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  PMID: 23045191 BACKGROUND

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  PMID: 22729992 BACKGROUND

• Manne SL, Ostroff JS, Norton TR, Fox K, Goldstein L, Grana G. Cancer-related relationship communication in couples coping with early stage breast cancer. Psychooncology. 2006 Mar;15(3):234-47. doi: 10.1002/pon.941.

  PMID: 15926198 BACKGROUND

• Northouse LL, Mood DW, Montie JE, Sandler HM, Forman JD, Hussain M, Pienta KJ, Smith DC, Sanda MG, Kershaw T. Living with prostate cancer: patients' and spouses' psychosocial status and quality of life. J Clin Oncol. 2007 Sep 20;25(27):4171-7. doi: 10.1200/JCO.2006.09.6503. Epub 2007 Jul 16.

  PMID: 17635953 BACKGROUND

• Kayser K, Scott J. (2008). Helping couples cope with women's cancer. New York : Springer.

  BACKGROUND

• Manne S, Badr H, Zaider T, Nelson C, Kissane D. Cancer-related communication, relationship intimacy, and psychological distress among couples coping with localized prostate cancer. J Cancer Surviv. 2010 Mar;4(1):74-85. doi: 10.1007/s11764-009-0109-y. Epub 2009 Dec 6.

  PMID: 19967408 BACKGROUND

• Porter LS, Keefe FJ, Baucom DH, Hurwitz H, Moser B, Patterson E, Kim HJ. Partner-assisted emotional disclosure for patients with gastrointestinal cancer: results from a randomized controlled trial. Cancer. 2009 Sep 15;115(18 Suppl):4326-38. doi: 10.1002/cncr.24578.

  PMID: 19731357 BACKGROUND

• Porter LS, Keefe FJ, Baucom DH, Hurwitz H, Moser B, Patterson E, Kim HJ. Partner-assisted emotional disclosure for patients with GI cancer: 8-week follow-up and processes associated with change. Support Care Cancer. 2012 Aug;20(8):1755-62. doi: 10.1007/s00520-011-1272-z. Epub 2011 Sep 24.

  PMID: 21947440 BACKGROUND

• Tiete J, Delvaux N, Lienard A, Razavi D. Efficacy of a dyadic intervention to improve communication between patients with cancer and their caregivers: A randomized pilot trial. Patient Educ Couns. 2021 Mar;104(3):563-570. doi: 10.1016/j.pec.2020.08.024. Epub 2020 Aug 27.

  PMID: 33129628 DERIVED

MeSH Terms

Conditions

Neoplasms; Communication

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Darius Razavi, MD, PhD

  Université Libre de Bruxelles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Randomization allocation is given only at the data manager. Participant, care provider and assessor do not know in which group participants are allocated
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Model Details: Randomized Controlled Trial

Study Record Dates

• First Submitted: October 23, 2018
• First Posted: October 29, 2018
• Study Start: July 3, 2017
• Primary Completion: August 24, 2018
• Study Completion: December 1, 2018
• Last Updated: December 4, 2018

Record last verified: 2018-12

Locations

BE (1)