Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Brown University | OTHER |
| Weill Medical College of Cornell University | OTHER |
| Johns Hopkins University | OTHER |
| Mclean Hospital |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AIM materials and assessments | Behavioral | 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:
Phase 4:
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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Phases 1 & 2:
Phase 3, Part 1 and 2:
Phase 3, Part 3:
Phase 4, Parts 2 and 3:
Exclusion Criteria:
Phases 1 & 2:
Phase 3:
Not provided
Not provided
Not provided
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.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Rebecca Saracino, PhD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
Not provided
| Label | URL |
|---|---|
| Memorial Sloan-Kettering Cancer Center | View source |
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Aug 30, 2023 | Aug 26, 2025 | ICF_000.pdf |
Not provided
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D007854 | Lead |
| ID | Term |
|---|---|
| D019216 | Metals, Heavy |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D008670 | Metals |
Not provided
Not provided
| OTHER |
| University of Southern California | OTHER |
| The New School for Social Research | OTHER |
Not provided
Not provided
Not provided
salvia
|
|
| 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. | 1 year |
| D017437 |
| Skin and Connective Tissue Diseases |