Cancer Clinical Trial
Official title:
Cancer-related Communication Between Patients and Their Caregivers: A Randomized Controlled Trial Assessing the Efficacy of a Dyadic Communication Reinforcement Intervention (DCRI)
NCT number | NCT03723122 |
Other study ID # | DCRI |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | July 3, 2017 |
Est. completion date | December 1, 2018 |
Verified date | December 2018 |
Source | Université Libre de Bruxelles |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 64 |
Est. completion date | December 1, 2018 |
Est. primary completion date | August 24, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - To read and speak French - To be aged 18 years old or more - To be diagnosed with any cancer type with a life expectancy of = 6 months or be the caregiver of patients meeting this inclusion criteria - To benefit from a folfox, folfiri, folfirinox or folfiri+bevacizumab-type chemotherapy with a life expectancy of = 6 months or be the caregiver of patients meeting this inclusion criteria Exclusion Criteria: - Not be treated for a psychiatric disorder |
Country | Name | City | State |
---|---|---|---|
Belgium | Hopital Erasme & Institut Jules Bordet | Brussels |
Lead Sponsor | Collaborator |
---|---|
Université Libre de Bruxelles |
Belgium,
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Kayser K, Scott J. (2008). Helping couples cope with women's cancer. New York : Springer.
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* Note: There are 13 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | Emotional Distress | Emotional distress levels through a validated self-reported scale for patients and caregivers: The Hospital Anxiety and Depression Scale (HADS). It is composed by 2 dimensions (anxiety and depression) and has a 4-point Likert scale that vary at each item. HADS provides a total score (0-42 range) by summing all item scores. A higher score reflects a higher emotional distress. Anxiety subscale score (0-21 range) is providen by summing all Anxiety-items. A higher score reflects more anxiety. Depression subscale scores (0-21 range) is providen by summing all Depression-items. A higher score reflects more depression. | 2 months |
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