Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Participants will complete an in-depth patient needs checklist to identify patient-specific barriers that could lead to a delay with starting chemotherapy.

Participants will follow routine clinical care, where chemotherapy start date is determined by the provider and patient.

The patient navigator will call you every week as described above in "Study Groups." These phone calls will continue until you begin receiving chemotherapy.

Navigator Phone Calls

Participants will be asked to complete an exit interview either in person or by phone

Exit Interview

Mariana Chavez Mac Gregor, MD

Project Lets start will provide individual support to breast cancer patients with the goal of reducing delay to chemotherapy initiation. In this study participants will identify areas of need and work with patient navigators who will provide weekly 1-1 support throughout patient's journey to beginning chemotherapy

OBJECTIVES:

Among patients with early-stage breast cancer, delays with the administration of chemotherapy significantly reduce its benefit. Interventions aimed at reducing TTC have the potential of improving outcomes and reducing health disparities. In this study we propose to develop an effective targeted intervention that is culturally sensitive and that addresses the roots of chemotherapy delay.

Our objective is to conduct a pilot study randomizing patients with breast cancer, in whom adjuvant or neoadjuvant chemotherapy has been recommended, to a culturally sensitive and patient-specific targeted intervention using patient navigators or routine clinical care

Primary Aim: To establish feasibility and acceptability.

We hypothesize that the intervention will be feasible and accepted by participants.

Secondary Aim: Explore TTC according to treatment arm. We hypothesize that the TTC will be shorter among participants randomized to the intervention

Exploratory Aim: 1) To determine if social support, interpersonal trust in a physician, and general self-efficacy changed from baseline to the end of the intervention; and 2) to determine if that change was similar between participants randomized to the intervention compared to the control arm.

We hypothesize that there will be favorable changes in scores among participants randomized to the intervention, while no change will occur among those randomized to the control arm.

A Feasibility and Acceptability Pilot Study Evaluating a Patient-Specific Targeted Intervention Using Patient Navigators or Routine Clinical Care

Responses are made on a 4-point scale, ranging from 1 (not at all true) to 4 (exactly true). Scores could range from a composite score of 10 to 40, with higher score indicating more self-efficacy.25

M.D. Anderson Cancer Center

Educational pamphlet with resources for sexual dysfunction

Participants randomized to this arm will only receive educational pamphlets with resources for sexual dysfunction and will not participate in physical therapy. Participants will be contacted at 3 months and 6 months to fill out two questionnaires about sexual function and quality of life. After 6months, if participants desire a referral to physical therapy, investigators will provide a referral.

Control Arm

Participants will receive a referral to begin a pelvic physical therapy regimen. Participants will complete the sexual function and quality of life questionnaires after completion of the physical therapy regimen and again 3 months after. There will be a brief exit interview.

Physical Therapy Arm

Questionnaire designed to measure cancer patients' physical, psychological and social functions

European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30)

19-item self-report inventory designed to assess female sexual function.

Female Sexual Function Index (FSFI)

11-item questionnaire for participants to give feedback to investigators about teir experience with the intervention.

Suzanne Danhauer, PhD

Anya Menzies, PhD

The purpose of this research study is to investigate the use of pelvic physical therapy for gynecologic cancer survivors who report sexual dysfunction. Physical therapy experts believe that a full 10-week regimen is necessary for true improvement of symptoms. Investigators aim to see if this tense regimen is feasible for survivors. Investigators also aim to see if patients have an improvement in their sexual function and quality of life.

Primary Objective(s): To determine the feasibility of an intensive pelvic physical therapy intervention with gynecologic cancer survivors reporting sexual dysfunction. Feasibility will be determined by accrual, retention, and adherence.

Secondary Objective(s):

* To demonstrate preliminary efficacy of the pelvic physical therapy intervention on sexual function in gynecologic cancer survivors. Sexual function will be measured three times: at time of randomization (T0), after completion of the 10-week pelvic physical therapy regimen - 3 months after randomization (T1), and 3 months after T1 (T2).
* To demonstrate preliminary efficacy of the pelvic physical therapy intervention on health-related quality of life in gynecologic cancer survivors. Quality of life will be measured at three times (T0) at time of randomization, (T1) after completion of the 10-week pelvic physical therapy regimen - 3 months after randomization, and (T2) 3 months after T1

Pelvic Physical Therapy for Sexual Dysfunction in Gynecologic Oncology Survivors

Feasibility of Pelvic Physical Therapy for Sexual Dysfunction in Gynecologic Oncology Survivors

Accrual is the number of participants that screen positive for sexual dysfunction, are eligible for entry into the study and consent to participate in the study.

Retention is participants' attendance of pelvic physical therapy visits.

Adherence is the number of enrolled participants completing the interevention.

The questionnaire is comprised of six domains: desire \[two items\], arousal \[four items\], lubrication \[four items\], orgasm, satisfaction, pain \[three items each\]. Score range is 1 to 5. The FSFI total score is the sum of the 6 domain/subscale scores and has a maximum score of 36. Higher scores indicate better functioning. At each time point, 2-sample t-tests or Wilcoxon rank sum tests will be used to compare sexual function between groups. If feasible, mixed effects models with random intercept will be used to compare sexual function between groups over time. Intervention groups, visits, and intervention groups by visits will be included in the model. Contrasts will be used to compare sexual function between groups at each time point.

The EORTC QLQ-C30 questionnaire will be completed three times during study intervention and is patient reported to assess sexual function and health-related quality of life. Score range is 0 to 100. A high score for a functional scale represents a high/ healthy level of functioning; a high score for the global health status /quality of life represents a high quality of life; a high score for a symptom scale/item represents a high level of symptomatology / problems. At each time point, 2-sample t-tests or Wilcoxon rank sum tests will be used to compare sexual function between groups. If feasible, mixed effects models with random intercept will be used to compare sexual function between groups over time. Intervention groups, visits, and intervention groups by visits will be included in the model. Contrasts will be used to compare sexual function between groups at each time point.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Feasibility and Acceptability Pilot Study Evaluating a Patient-Specific Targeted Intervention Using Patient Navigators or Routine Clinical Care	NCT05488444	Breast Cancer	Navigator Phone... Exit Interview	18 Years -	M.D. Anderson Cancer Center
Pelvic Physical Therapy for Sexual Dysfunction in Gynecologic Oncology Survivors	NCT05242770	Gynecologic Can... Sexual Dysfunct...	Control Arm Physical Therap... European Organi... Female Sexual F... Exit Interview	18 Years -	Wake Forest University Health Sciences
A Feasibility and Acceptability Pilot Study Evaluating a Patient-Specific Targeted Intervention Using Patient Navigators or Routine Clinical Care	NCT05488444	Breast Cancer	Navigator Phone... Exit Interview	18 Years -	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for exit interview