Cancer RecurrencePhase 1WiLLoWNCT01354041
Fear of Recurrence Pilot Intervention for Women With Breast Cancer
A Phase 1 study testing Acceptance and Commitment Therapy in people with Cancer Recurrence, run by University of California, San Francisco at 1 site in United States.
Trial summary
The primary objective of this pilot study is to examine the feasibility and acceptability of a randomized, controlled study of a mindfulness and values-based living intervention targeted at reducing fear of recurrence in breast cancer survivors compared to treatment as usual control. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cancer Recurrence
- What is being tested?
- Acceptance and Commitment Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2011to Dec 2012
- Phase
- Phase 1
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with early stage breast cancer within the past 18 months;
- Completed active treatment within the past year
- At least mild anxiety, and/or at least moderate fear of recurrence as measured by screening questionnaires.
- Ability to give written informed consent and willingness to comply with the requirements of the protocol
Who cannot join
- Presence of clinically significant cognitive impairment, or comorbid psychiatric or physical illness, only if, in the PI's or Co-Is' opinions, such illness would interfere with the ability to participate in and complete the intervention;
- Inability to speak and comprehend English sufficiently to complete the intervention.
- We will use a screening questionnaire (administered over the phone by the Research Associate) to determine that women do not have a comorbid physical or mental illness that is so impairing that they would be unable to participate in the groups or complete the measures.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco
San Francisco, California, 94143
About this study
Official title: A Pilot Intervention to Address Fear of Recurrence in Breast Cancer Survivors
The primary objective of this pilot study is to examine the feasibility and acceptability of a randomized, controlled study of a mindfulness and values-based living intervention targeted at reducing fear of recurrence in breast cancer survivors compared to treatment as usual control. Furthermore, the secondary objective of this randomized, controlled pilot study is to determine preliminary efficacy and effect size of the mindfulness and values-based living intervention compared to the treatment as usual control condition in reducing fear of recurrence in breast cancer survivors.
Read the detailed description
Fear of cancer recurrence (FCR) is pervasive, distressing and undermines quality of life in cancer survivors. For subgroups of survivors, FCR is implicated in both treatment non-adherence and medical over-utilization. Although some degree of FCR is nearly universal among cancer patients, effective psychological interventions have been understudied. Educational and cognitive approaches that have relied on reassurance may feed into the anxiety by encouraging experiential avoidance, according to behavioral theories of anxiety. Mindfulness and values based living approaches teach techniques for reducing experiential avoidance allowing patients to break this cycle and focus on functional, satisfying lives. Interventions based on these techniques offer promise for addressing FCR in breast cancer survivors.
- Conditions
- Cancer Recurrence
- Being tested
- Acceptance and Commitment Therapy
- Keywords
- fear and health worries about cancer recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acceptance and Commitment TherapyBehavioural
Also called ACT
Seven weekly sessions of Acceptance and Commitment Therapy (ACT) intervention
| Study group | Role | What they receive |
|---|---|---|
| Treatment-as-usual | No intervention | Participants in the Treatment as usual (TAU) arm will not receive any specific Fear of Cancer Recurrence (FCR) intervention during the study period. However, they will be offered an optional full-day workshop at the end of the study. |
| Acceptance and Commitment Therapy | Experimental | Participants in the intervention arm will receive seven sessions of a mindfulness and values-based living intervention, led by a trained licensed facilitator, conducted in groups of 10-12 participants and include components specifically designed to reduce FCR. The intervention arm will include six weekly 90 minute group sessions and one followup 90 minute group session "booster session" held three weeks later. The group sessions will be interactive and experiential and include homework practice for generalizing skills. Receives: Behavioral: Acceptance and Commitment Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fear of cancer recurrence
Multi-dimensional fear of recurrence measure.
Measured: Weeks 0, 6, 10, 30
Secondary outcomes (1)
Anxiety
Validated measure of anxiety.
Measured: Weeks 0, 6, 10, 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2011 (estimated)
- Study startMar 2011
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer RecurrenceStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laura B. Dunn, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01354041
- Sponsor's protocol ID
- 10-01831
- Acronym
- WiLLoW
- Status last verified
- Jan 2014
- First submitted
- 24 Feb 2011
- Last updated
- 27 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Intervention to Address Fear of Recurrence in Breast Cancer Survivors
- ClinicalTrials.gov ID
- NCT01354041
- Acronym / sponsor ID
- WiLLoW / 10-01831
- Conditions
- Cancer Recurrence
- Keywords
- fear and health worries about cancer recurrence
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 16 May 2011 (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.
The primary objective of this pilot study is to examine the feasibility and acceptability of a randomized, controlled study of a mindfulness and values-based living intervention targeted at reducing fear of recurrence in breast cancer survivors compared to treatment as usual control. Furthermore, the secondary objective of this randomized, controlled pilot study is to determine preliminary efficacy and effect size of the mindfulness and values-based living intervention compared to the treatment as usual control condition in reducing fear of recurrence in breast cancer survivors.
Detailed description
Fear of cancer recurrence (FCR) is pervasive, distressing and undermines quality of life in cancer survivors. For subgroups of survivors, FCR is implicated in both treatment non-adherence and medical over-utilization. Although some degree of FCR is nearly universal among cancer patients, effective psychological interventions have been understudied. Educational and cognitive approaches that have relied on reassurance may feed into the anxiety by encouraging experiential avoidance, according to behavioral theories of anxiety. Mindfulness and values based living approaches teach techniques for reducing experiential avoidance allowing patients to break this cycle and focus on functional, satisfying lives. Interventions based on these techniques offer promise for addressing FCR in breast cancer survivors.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment-as-usual | No intervention | –Participants in the Treatment as usual (TAU) arm will not receive any specific Fear of Cancer Recurrence (FCR) intervention during the study period. However, they will be offered an optional full-day workshop at the end of the study. |
| Acceptance and Commitment Therapy | Experimental | Behavioral: Acceptance and Commitment TherapyParticipants in the intervention arm will receive seven sessions of a mindfulness and values-based living intervention, led by a trained licensed facilitator, conducted in groups of 10-12 participants and include components specifically designed to reduce FCR. The intervention arm will include six weekly 90 minute group sessions and one followup 90 minute group session "booster session" held three weeks later. The group sessions will be interactive and experiential and include homework practice for generalizing skills. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosed with early stage breast cancer within the past 18 months;
- Completed active treatment within the past year
- At least mild anxiety, and/or at least moderate fear of recurrence as measured by screening questionnaires.
- Ability to give written informed consent and willingness to comply with the requirements of the protocol
Key exclusion criteria (3 listed)
- Presence of clinically significant cognitive impairment, or comorbid psychiatric or physical illness, only if, in the PI's or Co-Is' opinions, such illness would interfere with the ability to participate in and complete the intervention;
- Inability to speak and comprehend English sufficiently to complete the intervention.
- We will use a screening questionnaire (administered over the phone by the Research Associate) to determine that women do not have a comorbid physical or mental illness that is so impairing that they would be unable to participate in the groups or complete the measures.
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 TherapyAlso: ACTSeven weekly sessions of Acceptance and Commitment Therapy (ACT) intervention | Behavioural | Acceptance and Commitment Therapy |
Primary outcome
Fear of cancer recurrence
Time frame: Weeks 0, 6, 10, 30
Multi-dimensional fear of recurrence measure.
1 secondary outcome
Anxiety
Time frame: Weeks 0, 6, 10, 30
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 27 Jan 2014.
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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.
Laura B. Dunn, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Acceptance and Commitment Therapy in people with Cancer Recurrence, run by University of California, San Francisco 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 4 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 27 Jan 2014. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Fear of cancer recurrence (time frame: Weeks 0, 6, 10, 30). 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 27 Jan 2014.