Effects of a Lay-led Anxiety and Depression Self-management Program for Cancer Patients

NCT ID: NCT04537195

Last Updated: 2025-08-17

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 234 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-06
• Study Completion Date: 2026-02-01

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.

Conditions

Neoplasms; Anxiety; Self Efficacy; Psychological Distress; Cancer; Distress, Emotional; Depression; Group, Peer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Intervention Group

ADSMP-C

Group Type: EXPERIMENTAL

ADSMP-C

Intervention Type: BEHAVIORAL

A transdiagnostic, lay-led, group-based self-management program consisting of seven 2 ½ hour weekly sessions focusing on increasing patient self-efficacy in symptom management of anxiety and depression in cancer (ADSMP-C)

Control Group

Wait-list control group

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

ADSMP-C

A transdiagnostic, lay-led, group-based self-management program consisting of seven 2 ½ hour weekly sessions focusing on increasing patient self-efficacy in symptom management of anxiety and depression in cancer (ADSMP-C)

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

TrygFonden, Denmark

INDUSTRY

Sponsor Role: collaborator

Komiteen for Sundhedsoplysning

UNKNOWN

Sponsor Role: collaborator

Aarhus University Hospital

OTHER

Sponsor Role: collaborator

University of Aarhus

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Soren Christensen, MSc.

Role: PRINCIPAL_INVESTIGATOR

Dep. Psychology, Aarhus University, Denmark

Locations

Dep. Oncology, Aarhus University Hospital

Aarhus, , Denmark

Dep. Oncology, Regional Hospital West Jutland

Herning, , Denmark

Countries

Denmark

Other Identifiers

2016-051-000001, ID 1174

Identifier Type: OTHER

Identifier Source: secondary_id

124941, TrygFonden

Identifier Type: -

Identifier Source: org_study_id