Study of Oncology-Adapted Pain Reprocessing Therapy for Aromatase Inhibitor Associated Musculoskeletal Symptoms in Breast Cancer Survivors
NCT07934173, Not applicable, Not yet recruiting, University of Michigan Rogel Cancer Center
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Study of Oncology-Adapted Pain Reprocessing Therapy for Aromatase Inhibitor Associated Musculoskeletal Symptoms in Breast Cancer Survivors | ClinicalTrials.gov |
| NCT number | NCT07934173 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 44 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | University of Michigan Rogel Cancer Center | ClinicalTrials.gov |
| Conditions | Aromatase Inhibitor Therapy, Ductal Carcinoma in Situ, Hormone Receptor-positive Breast Cancer | ClinicalTrials.gov |
| Interventions | Pain Reprocessing Therapy (PRT) | ClinicalTrials.gov |
| First posted | 2026-11-12 | ClinicalTrials.gov |
| Last updated | 2026-11-12 | ClinicalTrials.gov |
Registered outcomes 14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Recruitment - Number | 11 months of recruitment activity | Number of approached patients who consent to participate. | ClinicalTrials.gov |
| Primary | Recruitment - proportion | 11 months of recruitment activity | Proportion of approached patients who consent to participate. | ClinicalTrials.gov |
| Primary | Retention - Assessments completed | 180 days | Mean number of post intervention assessments completed per subject; | ClinicalTrials.gov |
| Primary | Retention - Proportion | 180 days | proportion of subjects completing the Day 60 and Day 180 assessments | ClinicalTrials.gov |
| Primary | Intervention Uptake: PRT Sessions count | 60 days | Mean number of PRT sessions attended per subject | ClinicalTrials.gov |
| Primary | Intervention Uptake: proportions of participants | 60 days | proportion completing at least 4 of 6 sessions and proportion completing all 6 sessions. | ClinicalTrials.gov |
| Primary | Representativeness: | 11 months of enrollment activity | The demographic and clinical characteristics of enrolled participants vs. those of potentially eligible patients identified from the University of Michigan Rogel Cancer Center source population during the recruitment period. | ClinicalTrials.gov |
| Primary | Intervention fidelity. | 60 days of intervention | Intervention fidelity will be assessed through structured session checklists completed by interventionists after each visit, documenting delivery of required PRT components, session duration, and any deviations from the manual. | ClinicalTrials.gov |
| Primary | Acceptability of PRT intervention | after 60 days of intervention | Treatment Acceptability and Adherence Scale (TAAS), a 10-item scale assessing perceived acceptability and usefulness of a behavioral intervention.(Milosevic et al., 2015) Scores above the midpoint - 35 out of 70 - will denote moderate acceptability of the intervention). | ClinicalTrials.gov |
| Primary | Participant satisfaction | after 60 days of intervention | The CSQ-8 yields a total score ranging from 8 to 32, with higher scores indicating greater satisfaction. | ClinicalTrials.gov |
| Secondary | Pain severity | up to 180 days | Pain severity will be measured using a 0-10 Numeric Rating Scale (NRS) assessing average pain over the prior 7 days, with anchors of 0 ("no pain") and 10 ("worst pain imaginable") (Jensen et al., 1986). | ClinicalTrials.gov |
| Secondary | Change in Pain impact | up to 180 days | Pain impact will be assessed using the Pain, Enjoyment of Life, and General Activity (PEG) scale, a validated 3-item composite measure of pain severity and pain-related interference (Keller et al., 2004; Krebs et al., 2010). | ClinicalTrials.gov |
| Secondary | Pain Interferece | up to 180 days | Pain interference will be assessed using the PROMIS Pain Interference Short Form 6b, a 6-item measure evaluating the extent to which pain interferes with daily activities, social participation, and enjoyment of life over the past 7 days | ClinicalTrials.gov |
| Secondary | Physical Function T-scores | up to 180 days | Physical function will be measured using the PROMIS Physical Function 4a, a validated 4-item patient-reported measure of physical functioning. Scores will be converted to standardized T-scores, with higher scores indicating better physical function | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)