NeoplasmsADSMP-CNCT04537195
Effects of a Lay-led Anxiety and Depression Self-management Program for Cancer Patients
A study testing ADSMP-C in people with Neoplasms and Anxiety, run by University of Aarhus at 2 sites in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasms, Anxiety, Self Efficacy
- What is being tested?
- ADSMP-C
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 234 participants
- Where
- 2 sitesDenmark
- Study dates
- 6 Mar 2020to 1 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Not sufficient Danish language skills to fill Questionnaires and participate in a group based intervention
- Psychosis
- Aggressive behavior
- Imminent suicidal risk
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Dep. Oncology, Aarhus University Hospital
Aarhus, 8000
Dep. Oncology, Regional Hospital West Jutland
Herning, 7400
About this study
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
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.
Read the 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
- Being tested
- ADSMP-C
- Keywords
- Intervention, RCT
- Medical subject headings
- Neoplasms, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADSMP-CBehavioural
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)
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | ADSMP-C Receives: Behavioral: ADSMP-C |
| Control Group | No intervention | Wait-list control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Depressive Symptoms
Beck Depression Inventory (BDI-II)
Measured: Baseline and 3 months post-intervention
Change in Anxiety Symptoms
Spielberger State-Trait Inventory (STAI). State subscale.
Measured: Baseline and 3 months post-intervention
Secondary outcomes (7)
Change in Anxiety Symptoms
Spielberger State-Trait Inventory (STAI). State subscale.
Measured: Baseline and 6 months post-intervention
Change in Depressive Symptoms
Beck Depression Inventory (BDI-II)
Measured: Baseline and 6 months post-intervention
Change in Anxiety (observer-rated)
Hamilton Anxiety Rating Scale (HAM-A6)
Measured: Baseline and 7 months post-intervention
Change in Depression (observer-rated)
Hamilton Depression Rating Scale (HAM-D6)
Measured: Baseline and 7 months post-intervention
Change in Fear of cancer recurrence
Concerns About Recurrence Questionaire (CARQ-4)
Measured: Baseline and 3 months post-intervention
Change in Self-efficacy - Personal control
The Revised Illness Perception Questionnaire (IPQ-R). Personal Control subscale.
Measured: Baseline and 3 months post-intervention
Change in Self-efficacy - Social support
Obtain Help from Community, Family, Friends Scale (SECD-Ssup)
Measured: Baseline, and 3 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2020
- Study start6 Mar 2020
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeoplasmsStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 234 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- TrygFonden, Denmark, Komiteen for Sundhedsoplysning, Aarhus University Hospital
- Responsible party
- Sponsor
- Investigators
- Soren Christensen, MSc., Principal investigator, Dep. Psychology, Aarhus University, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04537195
- Sponsor's protocol ID
- 124941, TrygFonden
- Other IDs
- 2016-051-000001, ID 1174
- Acronym
- ADSMP-C
- Status last verified
- Aug 2025
- First submitted
- 27 Aug 2020
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: At the present the policy of Aarhus University does not allow the sharing of data according to GDPR rules. However this policy may be subject to change
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04537195
- Acronym / sponsor ID
- ADSMP-C / 124941, TrygFonden
- Conditions
- Neoplasms, Anxiety, Self Efficacy, Psychological Distress, Cancer, Distress, Emotional
- Keywords
- Intervention, RCT
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 234 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- TrygFonden, Denmark, Komiteen for Sundhedsoplysning, Aarhus University Hospital
- Study start
- 6 Mar 2020 (actual)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 3 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: ADSMP-CADSMP-C |
| Control Group | No intervention | –Wait-list control group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- Not sufficient Danish language skills to fill Questionnaires and participate in a group based intervention
- Psychosis
- Aggressive behavior
- Imminent suicidal risk
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ADSMP-CA 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) | Behavioural | Intervention Group |
Primary outcome
Change in Depressive Symptoms
Time frame: Baseline and 3 months post-intervention
Beck Depression Inventory (BDI-II)
Change in Anxiety Symptoms
Time frame: Baseline and 3 months post-intervention
Spielberger State-Trait Inventory (STAI). State subscale.
7 secondary outcomes
Change in Anxiety Symptoms
Time frame: Baseline and 6 months post-intervention
Change in Depressive Symptoms
Time frame: Baseline and 6 months post-intervention
Change in Anxiety (observer-rated)
Time frame: Baseline and 7 months post-intervention
Change in Depression (observer-rated)
Time frame: Baseline and 7 months post-intervention
Change in Fear of cancer recurrence
Time frame: Baseline and 3 months post-intervention
Change in Self-efficacy - Personal control
Time frame: Baseline and 3 months post-intervention
Change in Self-efficacy - Social support
Time frame: Baseline, and 3 months post-intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- Individual participant dataSharing planned: No. At the present the policy of Aarhus University does not allow the sharing of data according to GDPR rules. However this policy may be subject to change
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Soren Christensen, MSc. principal investigator
Dep. Psychology, Aarhus University, Denmark
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ADSMP-C in people with Neoplasms and Anxiety, run by University of Aarhus at 2 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Depressive Symptoms (time frame: Baseline and 3 months post-intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.