An interventional study of Pain Reprocessing Therapy (PRT) in Aromatase Inhibitor Therapy, Ductal Carcinoma in Situ and Hormone Receptor-positive Breast Cancer, sponsored by University of Michigan Rogel Cancer Center. Not yet recruiting. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-12.
Sponsored by University of Michigan Rogel Cancer Center · Not applicable, Interventional, and Supportive care
The goal of this study is to evaluate the feasibility, acceptability, and preliminary clinical effects of an oncology-adapted Pain Reprocessing Therapy (PRT) intervention for women with aromatase inhibitor-associated musculoskeletal symptoms (AIMSS). AIMSS is a common complication of aromatase inhibitor therapy for estrogen receptor-positive breast cancer and is associated with chronic pain, functional impairment, and premature discontinuation of endocrine therapy. The study will evaluate whether a six-session, manualized PRT intervention delivered remotely by trained palliative care therapists is feasible to implement and shows preliminary evidence of improving pain and physical function.
285 studies on the registry are indexed under Carcinoma, Intraductal, Noninfiltrating; 54 are open to participants now.
This study's planned enrollment of 44 is below the median of 66 across 207 interventional studies indexed under Carcinoma, Intraductal, Noninfiltrating.
Browse Carcinoma, Intraductal, Noninfiltrating studies →University of Michigan Rogel Cancer Center is the lead sponsor of 325 studies on the registry; 49 are open to participants now.
Of its 46 completed or terminated interventional studies of FDA-regulated products, 31 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
PRT is a form of psychotherapy that incorporates pain neuroscience education (reframing chronic pain as a predominantly safe signal arising from the brain and nervous system rather than as something that only arises from damaged tissues) with mindfulness meditation and graded exposure strategies. . For this study, PRT has been adapted for the oncology and cancer survivorship context, and includes attention to cancer-related uncertainty, fear of recurrence, medical trauma, treatment-related bodily changes, and concerns about pain as a possible signal of cancer progression. The intervention is manualized and delivered over six sessions.
Behavioral: Pain Reprocessing Therapy (PRT)
All participants will be asked only to participate in six 30-45 min intervention sessions. Participants will need to complete the sessions in the order specified. PRT will be delivered remotely by trained palliative care therapists using a HIPAA compliant secure video conferencing platform. Each session will last approximately 30-45 minutes. The intervention will be delivered in English only.
Recruitment - Number
Number of approached patients who consent to participate.
Time frame: 11 months of recruitment activity
Recruitment - proportion
Proportion of approached patients who consent to participate.
Time frame: 11 months of recruitment activity
Retention - Assessments completed
Mean number of post intervention assessments completed per subject;
Time frame: 180 days
Retention - Proportion
proportion of subjects completing the Day 60 and Day 180 assessments
Time frame: 180 days
Intervention Uptake: PRT Sessions count
Mean number of PRT sessions attended per subject
Time frame: 60 days
Intervention Uptake: proportions of participants
proportion completing at least 4 of 6 sessions and proportion completing all 6 sessions.
Time frame: 60 days
Representativeness:
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.
Time frame: 11 months of enrollment activity
Intervention fidelity.
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.
Time frame: 60 days of intervention
Acceptability of PRT 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).
Time frame: after 60 days of intervention
Participant satisfaction
The CSQ-8 yields a total score ranging from 8 to 32, with higher scores indicating greater satisfaction.
Time frame: after 60 days of intervention
Pain severity
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).
Time frame: up to 180 days
Change in Pain impact
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).
Time frame: up to 180 days
Pain Interferece
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
Time frame: up to 180 days
Physical Function T-scores
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
Time frame: up to 180 days
No study locations are listed for this record.
Plan to share: Yes — Deidentified patient quantitative data and qualitative transcripts will be provided to a data repository at the University of Colorado which will gather the data on behalf of the National Institute of Aging.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: within 12 months of last participant completing study
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for Feb 2029, 27 months later.
Of 44 non-industry interventional studies with no phase under Carcinoma, Intraductal, Noninfiltrating, half reached primary completion within 69 months of starting (the median), counting those still running; a quarter within 30 and three quarters within 148. This study's planned 27 months is below that.
Counting every sponsor, half of 47 studies reached it within 69 months; a quarter within 30 and three quarters within 134.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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