Benefits of MPACT in Locally Advanced Head and Neck Cancer Patients Undergoing Chemoradiotherapy

The goal of this study is to test, in a randomized controlled trial among head and neck cancer patients, the short and longer term effects of the MPACT (Maintaining Physical Activity during Cancer Treatment) program (infused with motivational interviewing and self-determination theory-based strategies) initiated at the time of concurrent chemotherapy with radiation (CCRT), on key outcomes such as functional mobility and quality of life, and ultimately physical activity. The central hypotheses is that in head and neck cancer patients undergoing CCRT, the MPACT program, as compared to usual care controls, will result in less acute decline, faster recovery, and better maintenance of these key outcomes.

Study Overview

• Status: Terminated
• Conditions: Head and Neck Neoplasms
• Intervention / Treatment: Other: MPACT

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • The University of Michigan Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients greater than or equal to 40 years old with AJCC (American Joint Committee on Cancer) stage II-IV head and neck squamous cell carcinoma who are beginning first-line non-surgical treatment with concurrent chemoradiotherapy (CCRT) and who are capable of understanding and adhering to the protocol requirements
• Patients must be willing to comply with the study procedures and visits.

Exclusion Criteria:

• Active or symptomatic cardiopulmonary disease
• Substantial dementia
• Acute medical conditions, such as acute flare-up of joint condition or infection
• Participants must not be actively receiving physical therapy in a relevant area, at the time of enrollment, or participating in intensive (30 min per day) aerobic program three times per week.
• Patients are actively being treated for another cancer at the time of enrollment
• Active or unstable metabolic conditions such as brittle diabetes or severe anemia
• Alcohol intake less than 3 ounces per day
• Hemiplegia or lower limb amputation
• Significant orthopedic or musculoskeletal condition that does not allow weight bearing
• Unable to maintain safe stance and walk, either with or without an assistive device

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual Care
Experimental: MPACT; A 7-week (7 weeks x 3 sessions per week), on site, functional resistance training (FRT) as well as a walking program concurrent with CCRT will be followed by a 7-week post-CCRT home program. The protocol follows American College of Sports Medicine (ACSM) prescription guidelines for cancer patients.	Other: MPACT; Maintaining Physical Activity during Cancer Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean change in 6 minute walk distance (6MWD)	6 MWD will be assessed at baseline, at weeks 4, 7, 11, and 14 and at 6 months and 1 year. The change from baseline will be calculated for each participant and longitudinal mixed models will be used to characterize mean outcomes over time for each intervention group.	1 Year

Collaborators and Investigators

• Sponsor: University of Michigan Rogel Cancer Center

Study record dates

Study Major Dates

• Study Start: February 1, 2016
• Primary Completion (Actual): October 1, 2018
• Study Completion (Actual): October 1, 2018

Study Registration Dates

• First Submitted: June 26, 2015
• First Submitted That Met QC Criteria: June 26, 2015
• First Posted (Estimate): June 30, 2015

Study Record Updates

• Last Update Posted (Actual): October 9, 2019
• Last Update Submitted That Met QC Criteria: October 7, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Head and Neck Neoplasms
• Other Study ID Numbers: UMCC 2015.073; HUM00100889 (Other Identifier: University of Michigan)