An Exercise and Nutrition Monitoring Intervention (Pt Pal) for the Improvement of Strength in Patients With Pancreatic or Stomach Cancer Receiving Chemoradiation Therapy Before Surgery, SurgeryStrong Study

NCT05056805 | Withdrawn

• 2 other identifiers: 2020-0026NCI-2021-02655
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This clinical trial studies the effectiveness of a home-based exercise and nutrition monitoring program called Pt Pal in improving strength in patients with pancreatic or stomach cancer receiving chemoradiation therapy before surgery. Pt Pal is a mobile health technology used to facilitate communication between the care team and the patient/caregiver, by allowing the care team to send from their web-portal, exercise routines, activities of daily living, diet recommendations, surveys and educational material to the patient/caregiver's mobile device. The Pt Pal application (app) then captures the patient/caregiver activity adherence data and reports those results back to the care team. The Pt Pal program may help improve overall strength in patients undergoing surgery for pancreatic and stomach cancer relative to standard care.

Conditions

Gastric Adenocarcinoma; Pancreatic Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• Change in dynamic lower muscle strength

  through study completion, an average of a year

Study Arms (2)

Arm A (aerobic exercise, nutritional recommendation)

ACTIVE COMPARATOR

Patients are encouraged to complete at least 30 minutes of moderate intensity aerobic exercise, at least 3 times per week. Patients receive nutrition consultation with a registered dietitian and monitor dietary intake. Aerobic exercises and nutrition are tracked in the Pt Pal app

Other: Aerobic Exercise; Other: Nutritional Intervention; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

Arm B (aerobic, strength exercise, nutritional recommendation)

EXPERIMENTAL

Patients complete at least 30 minutes of moderate intensity aerobic exercise (such as brisk walking or stationary bike cycling) at least 3 times per week. Patients also complete strength exercises with resistance tubes/bands at least 2 times per week, with at least 2 sets of 8-15 repetitions of the exercises taught. Patients receive nutrition consultation with a registered dietitian and monitor dietary intake. Patients also consume a high protein snack/meal/shake (15-25 grams) within 1 hour after any strengthening exercises. Exercise activities and nutrition are tracked in the Pt Pal app.

Other: Aerobic Exercise; Other: Dietary Intervention; Other: Nutritional Intervention; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Other: Resistance Training

Interventions

Aerobic Exercise OTHER

Receive aerobic exercise encouragement

Also known as: Aerobic Activity

Arm A (aerobic exercise, nutritional recommendation); Arm B (aerobic, strength exercise, nutritional recommendation)

Dietary Intervention OTHER

Consume high protein snack/meal/shake

Also known as: Dietary Modification, intervention, dietary, Nutrition Intervention, Nutrition Interventions, Nutritional Interventions

Arm B (aerobic, strength exercise, nutritional recommendation)

Nutritional Intervention OTHER

Receive nutritional consultation and guidelines

Arm A (aerobic exercise, nutritional recommendation); Arm B (aerobic, strength exercise, nutritional recommendation)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Arm A (aerobic exercise, nutritional recommendation); Arm B (aerobic, strength exercise, nutritional recommendation)

Questionnaire Administration OTHER

Ancillary studies

Arm A (aerobic exercise, nutritional recommendation); Arm B (aerobic, strength exercise, nutritional recommendation)

Resistance Training OTHER

Complete strengthening exercise

Also known as: Strength Training

Arm B (aerobic, strength exercise, nutritional recommendation)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pancreatic or gastric adenocarcinoma, biopsy-proven
• Have completed or are within 2 weeks of completion of preoperative chemoradiotherapy either on- or off-protocol
• Anticipated to undergo potentially curative resection in 4-6 weeks from enrollment
• Able to understand the description of the study and willing to participate
• Able to understand the exercise program
• Able to independently maintain daily exercise logs via Pt Pal -iOS, Android or desktop web browser on their own personal device
• Telephone or email access and agreement to engage with the research personnel via phone or email
• Meet all screening requirements, including physician clearance
• \>= age 18

You may not qualify if:

• Non-English speaking
• Has participated in moderate to high intensity strengthening exercises at least two times per week within the past four weeks prior to enrollment
• Unable to complete the baseline assessment questionnaires or functional assessments
• Underlying unstable cardiac or pulmonary disease or symptomatic cardiac disease (New York Heart Association functional class III or IV)
• Recent fracture or acute musculoskeletal injury that precludes the ability to weight bear fully on all 4 limbs in order to participate in an exercise intervention
• Numeric pain rating scale of \>= 7 out of 10
• Myopathic or rheumatologic disease that impacts physical function
• Recurrent cancer following prior resection
• \< age 18

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Related Links

• MD Anderson Cancer Center Website

MeSH Terms

Interventions

Exercise; Diet Therapy; Resistance Training

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Nutrition Therapy; Therapeutics; Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Physical Therapy Modalities; Physical Conditioning, Human

Study Officials

• Matthew H Katz

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2021
• First Posted: September 27, 2021
• Study Start: March 4, 2021
• Primary Completion: September 8, 2022
• Study Completion: September 8, 2022
• Last Updated: October 26, 2024

Record last verified: 2022-10