CancerNCT02550925
Acceptance and Commitment Therapy (ACT) for Anxious Cancer Survivors
A study testing Acceptance and Commitment Therapy (ACT) Group in people with Cancer, run by University of Colorado, Boulder at 1 site in United States.
Trial summary
This randomized clinical trial compares group acceptance and commitment therapy (ACT) to usual care for cancer survivors experiencing anxiety following the end of cancer treatment. Read more about this study
- Who is it for?
- Ages 21 to 95 yearsHealthy volunteers can take part
- Conditions the study is for
- Cancer
- What is being tested?
- Acceptance and Commitment Therapy (ACT) Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 139 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2015to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 21 to 95 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults in the Greater Boulder/ Denver, Colorado area who had cancer and completed primary cancer treatment (surgery, chemotherapy, and/or radiation) within the previous 18 months
- For solid tumor cancers: Show no current evidence of disease for solid-tumor cancers (of any cancer type or initial stage). For lymphoproliferative disorders such as chronic lymphocytic leukemia and indolent non-Hodgkin's lymphoma: In remission or asymptomatic after initial treatment and are followed with active surveillance.
- Screen positive for anxiety symptoms on the study screener
- Able to speak, read, and write English fluently
- Willing and able to participate in an ACT group once a week for 7 weeks
- Willing and able to complete online questionnaires and phone interviews at designated assessment points
Who cannot join
- Current moderate to high suicide risk
- History of chronic untreated trauma (unrelated to their cancer)
- Psychiatric hospitalization or suicide attempt in the past 5 years
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Boulder
Boulder, Colorado, 80303
About this study
Official title: A Novel Acceptance-Based Intervention for Anxious Cancer Survivors
This randomized clinical trial compares group acceptance and commitment therapy (ACT) to usual care for cancer survivors experiencing anxiety following the end of cancer treatment.
- Conditions
- Cancer
- Being tested
- Acceptance and Commitment Therapy (ACT) Group, Usual Care
- Keywords
- Cancer survivors
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acceptance and Commitment Therapy (ACT) GroupBehavioural
A 7-session Acceptance and Commitment Therapy (ACT) group intervention
Usual CareBehavioural
Check in with clinical social worker at oncology care site and obtain list of supportive resources
| Study group | Role | What they receive |
|---|---|---|
| Acceptance and Commitment Therapy Group | Experimental | Not described Receives: Behavioral: Acceptance and Commitment Therapy (ACT) Group |
| Usual Care | Active comparator | Not described Receives: Behavioral: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety symptoms
Method of assessment: questionnaire
Measured: Baseline to Post and (3- and 6-month) Follow Up
Secondary outcomes (6)
Depressive symptoms
Method of assessment: questionnaire
Measured: Baseline to Post and (3- and 6-month) Follow Up
Medical resource use
Method of assessment: survey of medical care use
Measured: Baseline to Post and (3- and 6-month) Follow Up
Fear of cancer recurrence
Method of assessment: questionnaire
Measured: Baseline to Post and (3- and 6-month) Follow Up
Sense of life meaning
Method of assessment: questionnaire
Measured: Baseline to Post and (3- and 6-month) Follow Up
Fatigue / Vitality
Method of assessment: questionnaire
Measured: Baseline to Post and (3- and 6-month) Follow Up
Anxiety disorder severity
Method of assessment: diagnostic interview
Measured: Baseline to Post and 6-month Follow Up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2015 (estimated)
- Study startSep 2015
- Primary completionAug 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 139 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Boulder
- Sponsor type
- University, hospital or other
- Collaborators
- American Cancer Society, Inc., Rocky Mountain Cancer Centers, University of California, Los Angeles
- Responsible party
- Principal investigator, Joanna Arch, University of Colorado, Boulder
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02550925
- Sponsor's protocol ID
- RSG-15-020-01
- Status last verified
- Mar 2020
- First submitted
- 30 Jul 2015
- Last updated
- 26 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Arch JJ, Mitchell JL. An Acceptance and Commitment Therapy (ACT) group intervention for cancer survivors experiencing anxiety at re-entry. Psychooncology. 2016 May;25(5):610-5. doi: 10.1002/pon.3890. Epub 2015 Jun 29. No abstract available.
PubMed 26130586Arch JJ, Mitchell JL, Genung SR, Judd CM, Andorsky DJ, Bricker JB, Stanton AL. Randomized trial of acceptance and commitment therapy for anxious cancer survivors in community clinics: Outcomes and moderators. J Consult Clin Psychol. 2021 Apr;89(4):327-340. doi: 10.1037/ccp0000630.
PubMed 34014694Arch JJ, Mitchell JL, Genung SR, Fisher R, Andorsky DJ, Stanton AL. A randomized controlled trial of a group acceptance-based intervention for cancer survivors experiencing anxiety at re-entry ('Valued Living'): study protocol. BMC Cancer. 2019 Jan 18;19(1):89. doi: 10.1186/s12885-019-5289-x.
PubMed 30658621
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Acceptance-Based Intervention for Anxious Cancer Survivors
- ClinicalTrials.gov ID
- NCT02550925
- Acronym / sponsor ID
- RSG-15-020-01
- Conditions
- Cancer
- Keywords
- Cancer survivors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 139 participants (actual)
- Lead sponsor
- University of Colorado, BoulderUniversity, hospital or other
- Collaborators
- American Cancer Society, Inc., Rocky Mountain Cancer Centers, University of California, Los Angeles
- Study start
- Sep 2015 (actual)
- Primary completion
- Aug 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 16 Sep 2015 (estimated)
- 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.
This randomized clinical trial compares group acceptance and commitment therapy (ACT) to usual care for cancer survivors experiencing anxiety following the end of cancer treatment.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acceptance and Commitment Therapy Group | Experimental | Behavioral: Acceptance and Commitment Therapy (ACT) Group |
| Usual Care | Active comparator | Behavioral: Usual Care |
Who may qualify
- Ages
- 21 to 95 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults in the Greater Boulder/ Denver, Colorado area who had cancer and completed primary cancer treatment (surgery, chemotherapy, and/or radiation) within the previous 18 months
- For solid tumor cancers: Show no current evidence of disease for solid-tumor cancers (of any cancer type or initial stage). For lymphoproliferative disorders such as chronic lymphocytic leukemia and indolent non-Hodgkin's lymphoma: In remission or asymptomatic after initial treatment and are followed with active surveillance.
- Screen positive for anxiety symptoms on the study screener
- Able to speak, read, and write English fluently
- Willing and able to participate in an ACT group once a week for 7 weeks
Key exclusion criteria (3 listed)
- Current moderate to high suicide risk
- History of chronic untreated trauma (unrelated to their cancer)
- Psychiatric hospitalization or suicide attempt in the past 5 years
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 |
|---|---|---|
| Acceptance and Commitment Therapy (ACT) GroupA 7-session Acceptance and Commitment Therapy (ACT) group intervention | Behavioural | Acceptance and Commitment Therapy Group |
| Usual CareCheck in with clinical social worker at oncology care site and obtain list of supportive resources | Behavioural | Usual Care |
Primary outcome
Anxiety symptoms
Time frame: Baseline to Post and (3- and 6-month) Follow Up
Method of assessment: questionnaire
6 secondary outcomes
Depressive symptoms
Time frame: Baseline to Post and (3- and 6-month) Follow Up
Medical resource use
Time frame: Baseline to Post and (3- and 6-month) Follow Up
Fear of cancer recurrence
Time frame: Baseline to Post and (3- and 6-month) Follow Up
Sense of life meaning
Time frame: Baseline to Post and (3- and 6-month) Follow Up
Fatigue / Vitality
Time frame: Baseline to Post and (3- and 6-month) Follow Up
Anxiety disorder severity
Time frame: Baseline to Post and 6-month Follow Up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2020.
- Background: PubMed 26130586Arch JJ, Mitchell JL. An Acceptance and Commitment Therapy (ACT) group intervention for cancer survivors experiencing anxiety at re-entry. Psychooncology. 2016 May;25(5):610-5. doi: 10.1002/pon.3890. Epub 2015 Jun 29. No abstract available.
- Derived from this study: PubMed 34014694Arch JJ, Mitchell JL, Genung SR, Judd CM, Andorsky DJ, Bricker JB, Stanton AL. Randomized trial of acceptance and commitment therapy for anxious cancer survivors in community clinics: Outcomes and moderators. J Consult Clin Psychol. 2021 Apr;89(4):327-340. doi: 10.1037/ccp0000630.
- Derived from this study: PubMed 30658621Arch JJ, Mitchell JL, Genung SR, Fisher R, Andorsky DJ, Stanton AL. A randomized controlled trial of a group acceptance-based intervention for cancer survivors experiencing anxiety at re-entry ('Valued Living'): study protocol. BMC Cancer. 2019 Jan 18;19(1):89. doi: 10.1186/s12885-019-5289-x.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acceptance and Commitment Therapy (ACT) Group in people with Cancer, run by University of Colorado, Boulder at 1 site in United States.
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 6 inclusion and 3 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: finished, as of the sponsor's last update on 26 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Anxiety symptoms (time frame: Baseline to Post and (3- and 6-month) Follow Up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02550925, which also lists 3 linked publications.
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 26 Mar 2020.