Clinical trial NCT04537195: Effects of a Lay-led Anxiety and Depression Self-management Program for Cancer Patients
Official title: Effects on Anxiety and Depression of a Lay-led Transdiagnostic Self-management Program (ADSMP-C) for Patients Recently Treated for Cancer With Curative Intent: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Neoplasms
Anxiety
Self Efficacy
Psychological Distress
Cancer
Distress, Emotional
Depression
Group, Peer
Keywords: Intervention
RCT
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: TrygFonden, Denmark
name: Komiteen for Sundhedsoplysning
name: Aarhus University Hospital
First posted: 2020-09-03
Enrollment: 234
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators aim to evaluate a peer-to-peer patient self-management program targeting symptoms of anxiety and depression in a randomized trial. A total of 234 cancer patients recently having completed primary treatment with curative intent in central Region Denmark will be included. The intervention is a lay-led, group-based transdiagnostic patient education program consisting of seven 2 ½ hour weekly sessions focusing on increasing patient self-efficacy in symptom management of anxiety and depression. The intervention is highly structured and manualized.

Detailed description: Recent evidence suggest that transdiagnostic interventions may be just as effective as traditional diagnosis specific interventions when treating symptoms of depression and anxiety. Brief lay-led transdiagnostic self-management interventions may therefore offer an efficient alternative to traditional symptom specific interventions (e.g. CBT) when targeting symptoms of depression and anxiety in cancer.

The present study aim to evaluate The Anxiety and Depression Symptom Management Program (ADSMP) in a cancer setting (ADSMP-C). The ADSMP is a Danish adaptation of The Stanford University Chronic Disease Self-Management Program (CDSMP) and is developed by the Danish Health Information Committee (In Danish: Komiteen for Sundhedsoplysning in collaboration with The Expert Patient Program Community Interest Company (EPPCIC), the English Health Service (NHS) and Stanford University.

The ADSMP-C is a lay-led, group-based transdiagnostic patient education program consisting of seven 2 ½ hour weekly sessions focusing on increasing patient self-efficacy in symptom management of anxiety and depression concluded with a networking session. The intervention is highly structured and manualized. Sub-group analyses on participants with a history of cancer in a larger trial of ADSMP conducted by members of the study group on behalf of the Danish National Board of Health showed promising results. However, a larger study is needed to establish sound scientific evidence on the effectiveness of the program in a cancer setting.

A total 234 cancer patients recently having completed primary treatment with curative intent in central Region Denmark will be randomized (2:1) to ADSMP-C or a control arm respectively. As a part of the recruitment procedure patients will be screened with The "Distress-Thermometer" at the departments of oncology at the two largest hospitals in Central Region, Denmark following primary treatment or at a follow-up (\< 1yrs. after primary treatment).

Participants completes online questionnaires (REDCap) at baseline (pre-randomization), at post-intervention, and at three (primary follow-up) and six months post-intervention, including the Beck's Depression Inventory (BDI-II) and Spielbergers State-Trait Anxiety Inventory (STAI-state) (primary outcomes). In addition, all participants will be interviewed at 7 month post-intervention. Outcome assessors, blind to group allocation, will perform observer-based Hamilton A6 and D6 short-form ratings at the interview (secondary outcomes).

Data will be evaluated by mixed-effects regression analyses (intention-to-treat).

The current study will be the first to evaluate the efficacy of ADSMP in a cancer setting.

Eligibility criteria: Inclusion Criteria:

* Treated in Central Region Denmark
* Recently completed (\< 1 yr.) primary treatment for cancer with curative intent
* BDI-II score \>=14 and/or STAI-state score \>=40

Exclusion Criteria:

* Not sufficient Danish language skills to fill Questionnaires and participate in a group based intervention
* Psychosis
* Aggressive behavior
* Imminent suicidal risk

Primary outcomes:
measure: Change in Depressive Symptoms
timeFrame: Baseline and 3 months post-intervention
measure: Change in Anxiety Symptoms
timeFrame: Baseline and 3 months post-intervention
Secondary outcomes:
measure: Change in Anxiety Symptoms
timeFrame: Baseline and 6 months post-intervention
measure: Change in Depressive Symptoms
timeFrame: Baseline and 6 months post-intervention
measure: Change in Anxiety (observer-rated)
timeFrame: Baseline and 7 months post-intervention
measure: Change in Depression (observer-rated)
timeFrame: Baseline and 7 months post-intervention
measure: Change in Fear of cancer recurrence
timeFrame: Baseline and 3 months post-intervention
measure: Change in Self-efficacy - Personal control
timeFrame: Baseline and 3 months post-intervention
measure: Change in Self-efficacy - Social support
timeFrame: Baseline, and 3 months post-intervention
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Dep. Oncology, Aarhus University Hospital
city: Herning
country: Denmark
facility: Dep. Oncology, Regional Hospital West Jutland
Study officials:
affiliation: Dep. Psychology, Aarhus University, Denmark
name: Soren Christensen, MSc.
role: PRINCIPAL_INVESTIGATOR
References: