CanDirect: Effectiveness of a Telephone-supported Depression Self-care Intervention for Cancer Survivors

NCT02890615 | Completed

• 1 other identifier: SMHC 16-15
• Study Type: interventional
• Target: 246
• Locations: 1 country
• Sites: 1

Brief Summary

Depressive symptoms are common in cancer survivors; 15% or more of cancer patients, even 1 year after diagnosis, experience depressive symptoms that can have a negative impact on their quality of life. Canadian care guidelines for cancer survivors recommend supporting the active engagement of survivors in their self-care. This study is an evaluation of the effect of a depression self-care program which includes a self-care toolkit and support in the form of regular telephone calls from a self-care coach. The toolkit contains tools that help cancer survivors:

1. 1.Learn new information to better understand depression. This can help people feel that they are not alone, and that their experience is not abnormal. Better understanding a condition also helps people feel more confident in their communications with health care professionals and can make it easier to share their experience with family and friends.
2. 2.Learn and practice new coping skills. This can help people feel confident that they can engage in the behaviours that have been shown to be beneficial for mood, e.g. restructuring thoughts, problem solving, and planning pleasant activities.

Conditions

Depression

Keywords

Survivors; Self Care

Outcome Measures

Primary Outcomes (1)

• Change in severity of depression symptoms: Centre for Epidemiologic Studies Depression Scale (CES-D)

  Baseline, 3 months, 6 months

Secondary Outcomes (5)

• Change in severity of anxiety symptoms: Hospital Anxiety and Depression Scale - Anxiety subscale (HADS-Anxiety)

  Baseline, 3 months, 6 months

• Change in mental and physical health-related quality of life: Short Form health survey (SF-12)

  Baseline, 3 months, 6 months

• Change in activation: Patient Activation Measure (PAM)

  Baseline, 3 months, 6 months

• Change in depression diagnosis: Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders - IV Disorders (SCID)

  Baseline, 6 months

• Change in use of health services: self-report

  Baseline, 3 month, 6 month

Study Arms (2)

Depression Self-care Intervention (SCI)

EXPERIMENTAL

Intervention group participants will receive the Depression Self-Care Toolkit for Cancer Survivors and will be supported by telephone by a coach who will help to activate them, guide them through the materials, help in selecting appropriate tools, and provide positive reinforcement. Coach contacts will be made every week for 3 months followed by 3 monthly contacts, up to a maximum of 15 contacts, lasting 10-20 minutes each. The coach uses a stepped approach (i.e. educate about depression, initiate mood monitoring, determine participant's goals with respect to reducing depressive symptoms, and help with the use of specific tools). A suggested script is provided for the coach as a framework for each call. Tailoring of the SCI to different participants will be based on problems, depressive symptoms (from the PHQ-9), or concerns a participant may raise during the call.

Behavioral: Depression self-care

Control group

NO INTERVENTION

Members of both groups will continue to receive "usual care" for their depression. We will not interfere with usual care beyond recommending that participants discuss their depressive symptoms with their doctor. If participants consent, a short progress report will be send to their treating physician at the end of the study. At each follow-up, we will ask participants about specific treatment they have received for depression since entering the study (antidepressant medication initiation, discontinuation, change of dose, or psychotherapy) and use of community resources. The Intervention group will receive the Depression SCI. The Control group will receive only usual care for 6 months after randomization; they will be given the Toolkit with a single coaching call upon completion of the final interview, to ensure their access to depression treatment.

Interventions

Depression self-care BEHAVIORAL

Toolkit and coaching

Depression Self-care Intervention (SCI)

Eligibility Criteria

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

You may qualify if:

• completed primary cancer treatment (surgery, radiation and/or chemotherapy) for any type of cancer (NB: patients receiving adjuvant therapies will be eligible),
• between 1-10 years post-diagnosis (as suggested by clinicians collaborating on the project),
• with moderate depressive symptoms (PHQ-9 score of 8-19).

You may not qualify if:

• metastatic disease,
• suicidal,
• moderate-severe cognitive impairment,
• unable to speak and read in English or French,
• only non-melanoma skin cancer (without any other single primary cancer),
• receiving ongoing psychological treatment at baseline (because of recent finding that this treatment may negatively modify the effectiveness of the coaching component of the intervention). NB: those who begin psychological treatment during follow-up will not be withdrawn.
• dose of antidepressant medication changed within last 6 weeks at baseline. NB: those who change dose or treatment during follow-up will not be withdrawn.

Sponsors & Collaborators

• McGill University: lead

Study Sites (1)

St Mary's Research Centre

Montreal, Quebec, H3T1M5, Canada

Location

Related Publications (1)

• McCusker J, Jones JM, Li M, Faria R, Yaffe MJ, Lambert SD, Ciampi A, Belzile E, de Raad M. CanDirect: Effectiveness of a Telephone-Supported Depression Self-Care Intervention for Cancer Survivors. J Clin Oncol. 2021 Apr 1;39(10):1150-1161. doi: 10.1200/JCO.20.01802. Epub 2021 Feb 8.

  PMID: 33555912 DERIVED

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Emerita and Full Professor Post-Retirement

Study Record Dates

• First Submitted: August 24, 2016
• First Posted: September 7, 2016
• Study Start: July 1, 2016
• Primary Completion: April 1, 2019
• Study Completion: June 1, 2019
• Last Updated: February 19, 2020

Record last verified: 2020-02

Locations

CA (1)