Breast CancerNCT01517945
Attention and Interpretation Modification (AIM) for Fear of Cancer Recurrence: An Intervention Development Study
An observational study of Breast Cancer and Rare Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
The purpose of this study is to test, customize, and personalize a mobile app-based intervention program in order to help rare and breast cancer survivors cope with fears of cancer recurrence. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Rare Cancer
- What is being tested?
- AIM materials and assessments
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 252 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to Jan 2027
- Phase
- Observational
- 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
Study population: Rare and Breast cancer survivors will be recruited to the study. There are no physical recruitment sites outside of MSKCC. Participants may be patients who were treated at MSKCC or rare or breast cancer survivors who were treated elsewhere and learned about the study through an advertisement. The study summary and research team contact information will be available/advertised in the community through MSKCC Connections, MSKCC Survivorship Program and the American Cancer Society website.
Who may be able to join
- Phases 1 \& 2:
- Breast cancer survivors
- Hx of early-stage breast cancer (DCIS and Stages I, II and III)as recorded in the medical record at MSK or by self-report or by outside correspondence, including a study checklist signed by a physician for patients outside of MSK.
- ≥ 3 months post completion of breast cancer treatment (may be on hormone therapy, such as tamoxifen) with no history of recurrence or metastasis as confirmed by the medical record at MSK, self- report or by outside correspondence
- Age 18 or older
- Able to read and speak English
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- An overall fear index score of ≥ 3.0 on the CARS
- If taking medication for mood, anxiety, depression, thoughts, sensory experiences such as hallucinations, or sleep, stable and consistent enough in dosage and use of that medication so as to not result in a clinically significant change as determined by the study PI/co-PI or confirmed by reports in the medical record at MSK or by self-report or by outside correspondence, including a study checklist signed by a physician for patients outside of MSK
- If in non-CBT psychotherapy, stable for at least 8 weeks
- Access to a computer or willingness to come to MSK to complete intervention sessions 2-8 and the 3-month follow-up assessment, if no personal computer.
- For Part 2 only, did not participate in Part 1
- Phase 3, Part 1 and 2:
- Hx of early-stage breast cancer (DCIS and Stages I, II, and III) as recorded in the medical record at MSK or by self-report or by outside correspondence, including a study checklist signed by a physician for patients outside of MSK
- Completion of breast cancer treatment (may be on hormone therapy, such as tamoxifen) with no history of recurrence or metastasis as confirmed by the medical record at MSK, by self-report, or by outside correspondence
- Age 18 or older
- English fluency: self-report by subject identifying English as the preferred language for healthcare, and self-reported degree of fluency as speaking English "Very well."
- Score of >/= 12 on the 8-item Cancer Worry Scale
- Score of >/= 2 SDs below the mean on the euro-QOL-Short Form
- Uses an iOS mobile device (may be an iPad)
- If taking medication for mood, anxiety, depression, thoughts, sensory experiences such as hallucinations, or sleep, stable for at least 8 weeks and consistent enough in dosage and use of that medication so as to not result in a clinically significant change as determined by the study PI/co-PI or confirmed by reports in the medical record at MSK or by self-report or by outside correspondence, including a study checklist signed by a physician for patients outside of MSK.
- Phase 3, Part 3:
- Hx of early-stage breast cancer (DCIS and Stages I, II, and III) with no history of metastasis as per EMR, by self-report, or by outside correspondence.
- Completion of breast cancer treatment (may be on hormone therapy, such as tamoxifen, or on maintenance medication) as per the EMR or self-report.
- Age 18 or older as per the EMR or self-report.
- English fluency: Self-report by subject identifying English as the preferred language for healthcare, and self-reported degree of fluency as speaking English "Very well"
- Score ≥ 9 on the 6-item Cancer Worry Scale (CWS: this score was found to be optimal to screen for high FCR across cancer types)
- Score of > 2 SDs below the mean on the Neuro-QOL-Short Form
- Uses an iOS mobile device (may be an iPad) as per self-report.
- If taking medication for mood, anxiety, depression, thoughts, sensory experiences such as hallucinations, or sleep, stable for at least 8 weeks and consistent enough in dosage and use of that medication so as to not result in a clinically significant change as determined by the study PI/co-PI or confirmed by the EMR or by self-report or by outside correspondence including a study checklist signed by a physician for patients outside of MSK
- Must reside in the United States.
- Phase 4, Parts 2 and 3:
- Hx of early stage (Stages 0, I, II, and III) rare melanoma subtypes (e.g., acral, uveal) and skin (excluding keratinocyte cancers, e.g., basal and squamous cell), gynecological, long-term adult, pediatric rare liquid cancer (in remission only) or other rare cancer per the EMR, by self-report, or by outside correspondence.
- Age 18 or older, as per the EMR or self-report.
- English fluency: Self-report by subject identifying English as the preferred language for healthcare, and self-reported degree of fluency as speaking English "Very well."
- Score ≥ 9 on the 6-item Cancer Worry Scale (CWS; this score was found to be optimal to screen for high FCR across cancer types)
- Score of >2 SDs below the mean on the Neuro-QOL - Short Form
- Uses an iOS mobile device (may be an iPad) as per self-report.
- If taking medication for mood, anxiety, depression, thoughts, sensory experiences such as hallucinations, or sleep, stable for at least 8 weeks and consistent enough in dosage and use of that medication so as to not result in a clinically significant change as determined by the study PI/co-PI or confirmed by the EMR or by self-report or by outside correspondence, including a study checklist signed by a physician for patients outside of MSK
- Completed active treatment (can be on hormonal therapy or on maintenance medication) as per the EMR or self-report.
- Must reside in the United States.
Who cannot join
- Phases 1 \& 2:
- Evidence of or treatment for a second primary of cancer EXCEPT basal or squamous cell carcinoma of the skin as confirmed by the EMR, by self-report, or by outside correspondence
- Significant psychiatric or cognitive disturbance sufficient, to preclude providing informed consent or participating in the interventions (i.e., acute psychiatric symptoms which require individual treatment) as determined by the study PI/co-PI or confirmed by the EMR or by self-report or by outside correspondence
- Current participation in cognitive-behavioral therapy (CBT), as confirmed by either self-report* or the EMR, also targets cognitive biases.
- Phase 3:
- Evidence of or treatment for a second primary cancer EXCEPT basal or squamous cell carcinoma of the skin as confirmed by the medical record at MSK, by self-report, or by outside correspondence
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- Metastatic disease
- Score of </= SDs below the mean on the Neuro-QOL-Short Form or other indicators of significant cognitive impairment of psychiatric disturbance that, in the PI's judgment, precludes participation; and currently receiving cognitive-behavioral therapy.
- Phase 4:
- Metastatic disease as per the EMR or self-report.
- Score of ≤ 2 SDs below mean of the Neuro-QoL- Short Form or other indicators of significant cognitive impairment or psychiatric disturbance that, in the PI's judgment, precludes participation; and currently receiving cognitive-behavioral therapy.
- Participants will be invited to complete assessments of salivary cortisol and/or EEG as part of Phase 4, Part 3 study activities. Those who decline completion of these assessments will still be eligible to participate in the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
The purpose of this study is to test, customize, and personalize a mobile app-based intervention program in order to help rare and breast cancer survivors cope with fears of cancer recurrence.
- Conditions
- Breast Cancer, Rare Cancer
- Being tested
- AIM materials and assessments
- Keywords
- Survivors, Quality of Life, Questionnaire, 11-204, Rare Cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AIM materials and assessmentsBehavioural
Also called In situations where there are unanticipated and unavoidable session delays, we, will work with the participants to ensure that all sessions are completed over, no more than 12 weeks A follow-up session will be scheduled 3 months as far, back as 2 weeks before and as far out as 6 weeks after) after the completion
Phase 1 (complete) - dev of AIM materials targeting fear of cancer recurrence in BCS (n = 10).
Phase 2 (complete) - randomized, single-blind, placebo-controlled, proof-of-concept pilot trial.
Phase 3:
- Part 1 of Phase 3 (complete) - dev of of iThrive app for BCS
- Part 2 of Phase 3 (complete) - usability testing by observing navigation with BCS in a laboratory setting
- Part 3 of Phase 3 - acceptability of iThrive will be assessed through a small RCT (n=30)
Phase 4:
- Part 1 of Phase 4 (complete) - dev of iThrive app for RCS
- Part 2 of Phase 4 (complete) - usability testing completed by observing navigation with RCS remotely
- Part 3 of Phase 4 - acceptability of iThrive will be assessed through a small RCT (n=90)
For Phases 3 and 4, Part 3: We will work with participants to ensure that sessions are completed over < 12 weeks if unavoidable delays occur. A follow-up session will be scheduled 3 months after completion of the last session.
| Study group | Role | What they receive |
|---|---|---|
| Breast cancer survivors and Rare cancer survivors | This is a Cycle for Survival and Center for Translational Science Center (CTSC)-funded intervention development and pilot clinical trial of a psychosocial intervention to address fear of cancer recurrence in breast cancer survivors (BCS) and rare cancer survivors (RCS). BCS form the largest survivor cohort of any cancer, with approximately 2.5 million living in the United States. About 50 percent of people with cancer have a rare cancer. Even though they account for about half of all cancer diagnoses when combined, research aimed at supporting RCS is sparse, leaving RCS with limited support after treatment. Receives: Behavioral: AIM materials and assessments |
What is being measured
The primary outcome is the main question the study is designed to answer.
Develop and refine materials (iThrive and iTrack)
This will involve development of a mobile app-based intervention program (based on our results from Phase 1 and 2 and preliminary work conducted by Beard et al.) that targets fear of cancer recurrence for breast, rare gynecological, rare melanoma and skin, long-term adult pediatric, and other rare cancer survivors.
Measured: 1 year
Secondary outcomes (2)
Determine feasibility, usability, acceptability
We will evaluate three versions of the app-based intervention program (iThrive 8, iThrive 16, and iTrack) in BCS (n=30) and RCS (n=90). This will allow us to assess the feasibility of the research procedures, the appropriateness of the psychological and physiological outcome measures, preliminary estimates of pre- and post-intervention effect sizes and reliable change estimates, and variables associated with any observed outcomes.
Measured: 1 year
Preliminary Efficacy
We will evaluate three versions of the app-based intervention program (iThrive 8, iThrive 16, and iTrack) in BCS (n=30) and RCS (n=90). This will allow us to assess the feasibility of the research procedures, the appropriateness of the psychological and physiological outcome measures, preliminary estimates of pre- and post-intervention effect sizes and reliable change estimates, and variables associated with any observed outcomes.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2012 (estimated)
- Study startJan 2012
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 252 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Brown University, Weill Medical College of Cornell University, Johns Hopkins University, Mclean Hospital, University of Southern California, The New School for Social Research
- Responsible party
- Sponsor
- Investigators
- Rebecca Saracino, PhD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01517945
- Sponsor's protocol ID
- 11-204
- Status last verified
- Apr 2026
- First submitted
- 20 Jan 2012
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Attention and Interpretation Modification (AIM) for Fear of Cancer Recurrence: An Intervention Development Study
- ClinicalTrials.gov ID
- NCT01517945
- Acronym / sponsor ID
- 11-204
- Conditions
- Breast Cancer, Rare Cancer
- Keywords
- Survivors, Quality of Life, Questionnaire, 11-204, Rare Cancer
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 252 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- Brown University, Weill Medical College of Cornell University, Johns Hopkins University, Mclean Hospital, University of Southern California, The New School for Social Research
- Study start
- Jan 2012
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 25 Jan 2012 (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 purpose of this study is to test, customize, and personalize a mobile app-based intervention program in order to help rare and breast cancer survivors cope with fears of cancer recurrence.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Breast cancer survivors and Rare cancer survivors | – | Behavioral: AIM materials and assessmentsThis is a Cycle for Survival and Center for Translational Science Center (CTSC)-funded intervention development and pilot clinical trial of a psychosocial intervention to address fear of cancer recurrence in breast cancer survivors (BCS) and rare cancer survivors (RCS). BCS form the largest survivor cohort of any cancer, with approximately 2.5 million living in the United States. About 50 percent of people with cancer have a rare cancer. Even though they account for about half of all cancer diagnoses when combined, research aimed at supporting RCS is sparse, leaving RCS with limited support after treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Rare and Breast cancer survivors will be recruited to the study. There are no physical recruitment sites outside of MSKCC. Participants may be patients who were treated at MSKCC or rare or breast cancer survivors who were treated elsewhere and learned about the study through an advertisement. The study summary and research team contact information will be available/advertised in the community through MSKCC Connections, MSKCC Survivorship Program and the American Cancer Society website.
Key inclusion criteria (40 listed)
- Breast cancer survivors
- Hx of early-stage breast cancer (DCIS and Stages I, II and III)as recorded in the medical record at MSK or by self-report or by outside correspondence, including a study checklist signed by a physician for patients outside of MSK.
- ≥ 3 months post completion of breast cancer treatment (may be on hormone therapy, such as tamoxifen) with no history of recurrence or metastasis as confirmed by the medical record at MSK, self- report or by outside correspondence
- Age 18 or older
- Able to read and speak English
Key exclusion criteria (12 listed)
- Evidence of or treatment for a second primary of cancer EXCEPT basal or squamous cell carcinoma of the skin as confirmed by the EMR, by self-report, or by outside correspondence
- Significant psychiatric or cognitive disturbance sufficient, to preclude providing informed consent or participating in the interventions (i.e., acute psychiatric symptoms which require individual treatment) as determined by the study PI/co-PI or confirmed by the EMR or by self-report or by outside correspondence
- Current participation in cognitive-behavioral therapy (CBT), as confirmed by either self-report* or the EMR, also targets cognitive biases.
- Evidence of or treatment for a second primary cancer EXCEPT basal or squamous cell carcinoma of the skin as confirmed by the medical record at MSK, by self-report, or by outside correspondence
- Metastatic disease
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 |
|---|---|---|
| AIM materials and assessmentsAlso: In situations where there are unanticipated and unavoidable session delays, we, will work with the participants to ensure that all sessions are completed over, no more than 12 weeks A follow-up session will be scheduled 3 months as far, back as 2 weeks before and as far out as 6 weeks after) after the completionPhase 1 (complete) - dev of AIM materials targeting fear of cancer recurrence in BCS (n = 10). Phase 2 (complete) - randomized, single-blind, placebo-controlled, proof-of-concept pilot trial. Phase 3: * Part 1 of Phase 3 (complete) - dev of of iThrive app for BCS * Part 2 of Phase 3 (complete) - usability testing by observing navigation with BCS in a laboratory setting * Part 3 of Phase 3 - acceptability of iThrive will be assessed through a small RCT (n=30) Phase 4: * Part 1 of Phase 4 (complete) - dev of iThrive app for RCS * Part 2 of Phase 4 (complete) - usability testing completed by observing navigation with RCS remotely * Part 3 of Phase 4 - acceptability of iThrive will be assessed through a small RCT (n=90) For Phases 3 and 4, Part 3: We will work with participants to ensure that sessions are completed over < 12 weeks if unavoidable delays occur. A follow-up session will be scheduled 3 months after completion of the last session. | Behavioural | Breast cancer survivors and Rare cancer survivors |
Primary outcome
Develop and refine materials (iThrive and iTrack)
Time frame: 1 year
This will involve development of a mobile app-based intervention program (based on our results from Phase 1 and 2 and preliminary work conducted by Beard et al.) that targets fear of cancer recurrence for breast, rare gynecological, rare melanoma and skin, long-term adult pediatric, and other rare cancer survivors.
2 secondary outcomes
Determine feasibility, usability, acceptability
Time frame: 1 year
Preliminary Efficacy
Time frame: 1 year
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 24 Apr 2026.
- Memorial Sloan-Kettering Cancer CenterLink provided by the sponsor.
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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.
Rebecca Saracino, PhD principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Rare Cancer, run by Memorial Sloan Kettering Cancer Center 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 40 inclusion and 12 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 24 Apr 2026. 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?
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?
Develop and refine materials (iThrive and iTrack) (time frame: 1 year). 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 24 Apr 2026.