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

NCT04537195 | Active Not Recruiting

• 2 other identifiers: 124941, TrygFonden2016-051-000001, ID 1174
• Study Type: interventional
• Target: 234
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Keywords

Intervention; RCT

Outcome Measures

Primary Outcomes (2)

• Change in Depressive Symptoms

  Beck Depression Inventory (BDI-II)

  Baseline and 3 months post-intervention

• Change in Anxiety Symptoms

  Spielberger State-Trait Inventory (STAI). State subscale.

  Baseline and 3 months post-intervention

Secondary Outcomes (7)

• Change in Anxiety Symptoms

  Baseline and 6 months post-intervention

• Change in Depressive Symptoms

  Baseline and 6 months post-intervention

• Change in Anxiety (observer-rated)

  Baseline and 7 months post-intervention

• Change in Depression (observer-rated)

  Baseline and 7 months post-intervention

• Change in Fear of cancer recurrence

  Baseline and 3 months post-intervention

Study Arms (2)

Intervention Group

EXPERIMENTAL

ADSMP-C

Behavioral: ADSMP-C

Control Group

NO INTERVENTION

Wait-list control group

Interventions

ADSMP-C 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)

Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Aarhus: lead
• TrygFonden, Denmark: collaborator
• Komiteen for Sundhedsoplysning: collaborator
• Aarhus University Hospital: collaborator

Study Sites (2)

Dep. Oncology, Aarhus University Hospital

Aarhus, 8000, Denmark

Location

Dep. Oncology, Regional Hospital West Jutland

Herning, 7400, Denmark

Location

MeSH Terms

Conditions

Neoplasms; Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Soren Christensen, MSc.

  Dep. Psychology, Aarhus University, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Assessors will be blinded at 7-month follow-up when administering the Hamilton rating scales (secondary outcomes). Participants will be instructed not to disclose their group allocation until the interview is completed
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2020
• First Posted: September 3, 2020
• Study Start: March 6, 2020
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: March 4, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

DK (2)