Mind-Body Health in Uro-Oncology: Research Study

Sponsor

Northwestern University (Other)

Overall Status

Completed

CT.gov ID

NCT03852030

Collaborator

NorthShore University HealthSystem (Other)

120

Enrollment

Locations

Arms

Actual Duration (Months)

Patients Per Site

1.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

In this study, the researchers will examine the effects of post-mindfulness intervention email and text messages to promote maintenance of intervention effects over time in a uro-oncology sample (clinically localized prostate, kidney, and bladder cancer) of patients and spouses.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer Kidney Cancer Bladder Cancer	Behavioral: Text or email message	N/A

Detailed Description

Participant accrual will occur at NorthShore University HealthSystem's John and Carol Walter Center for Urological Health. During or prior to an office visit, a potential subject and possibly his/her spouse will speak with the physician or research staff to assess interest in discussing the study. All eligible participants will be enrolled into an 8-week mindfulness-based stress reduction (MBSR) course. Because the course content focuses on training in mindfulness meditation (and not cancer-specific issues), the researchers will allow for mixed cancer classes. Prior to the first class, all participants will complete baseline standardized patient reported outcomes (PROs) of health related quality of life, and undergo blood collection via finger prick. Following participation in the 8-week course, participants will complete their 8-week PRO and bio-marker assessments in a similar manner, and will be randomized to either 4 months of: 1) weekly mindfulness-specific text or email messages related to course teachings, 2) weekly general/informational texts or emails about healthy living and lifestyle, or 3) no texts or emails. PRO and bio-marker assessments will also be administered at 6 months, and PRO measures will be collected at 12 months.

Study Design

Study Type:

Interventional

Actual Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Following participation in the 8-week course, participants will be randomized to either 4 months of: 1) weekly MBSR specific text or email messages related to course teachings, 2) weekly general/informational texts or emails about healthy living and lifestyle, or 3) no texts or emails.Following participation in the 8-week course, participants will be randomized to either 4 months of: 1) weekly MBSR specific text or email messages related to course teachings, 2) weekly general/informational texts or emails about healthy living and lifestyle, or 3) no texts or emails.

Masking:

Single (Participant)

Masking Description:

Participants were not told to which weekly text messaging group they were being assigned, or about the other groups.

Primary Purpose:

Supportive Care

Official Title:

Mind-Body Health in Uro-Oncology: A Randomized Controlled Trial

Actual Study Start Date :

Jul 1, 2012

Actual Primary Completion Date :

Jul 1, 2016

Actual Study Completion Date :

Jul 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Mindfulness text/email message Weekly MBSR specific text or email messages related to course teachings were sent. TYPES OF MESSAGES INCLUDED: Non-reaction; Non-Judgment; Awareness; Loving Kindness; Acceptance.	Behavioral: Text or email message Text or email messages sent to research participants
Placebo Comparator: Health promotion text/email message Weekly general/informational texts or emails about healthy living and lifestyle were sent. TYPES OF MESSAGES INCLUDED: Diet; Exercise; Sleep; Illness; Stress.	Behavioral: Text or email message Text or email messages sent to research participants
No Intervention: No text/email message No texts or emails were sent. There are no examples or descriptions for these messages, because no messages were sent to this group.

Arm

Intervention/Treatment

Experimental: Mindfulness text/email message

Weekly MBSR specific text or email messages related to course teachings were sent. TYPES OF MESSAGES INCLUDED: Non-reaction; Non-Judgment; Awareness; Loving Kindness; Acceptance.

Behavioral: Text or email message

Text or email messages sent to research participants

Placebo Comparator: Health promotion text/email message

Weekly general/informational texts or emails about healthy living and lifestyle were sent. TYPES OF MESSAGES INCLUDED: Diet; Exercise; Sleep; Illness; Stress.

Behavioral: Text or email message

Text or email messages sent to research participants

No Intervention: No text/email message

No texts or emails were sent. There are no examples or descriptions for these messages, because no messages were sent to this group.

Outcome Measures

Primary Outcome Measures

change in fatigue using the PROMIS Fatigue questionnaire [baseline, 8 weeks, 6 months, 12 months]
Examine change in fatigue between the intervention arms by comparing the responses on the PROMIS Fatigue questionnaire
change in depression using the PROMIS Depression questionnaire [baseline, 8 weeks, 6 months, 12 months]
Examine change in depression between the intervention arms by comparing the responses on the PROMIS Depression questionnaire
change in anxiety using the PROMIS Anxiety questionnaire [baseline, 8 weeks, 6 months, 12 months]
Examine change in anxiety between the intervention arms by comparing the responses on the PROMIS Anxiety questionnaire
change in sleep using the PROMIS Sleep Disturbance questionnaire [baseline, 8 weeks, 6 months, 12 months]
Examine change in sleep between the intervention arms by comparing the responses on the PROMIS Sleep Disturbance questionnaire
change in physical function using the PROMIS Physical Function questionnaire [baseline, 8 weeks, 6 months, 12 months]
Examine change in physical function between the intervention arms by comparing the responses on the PROMIS Physical Function questionnaire
change in stress using the State-Based Stress Visual Analogue Scale [baseline, 8 weeks, 6 months, 12 months]
Examine change in stress between the intervention arms by comparing the responses on the State-Based Stress Visual Analogue Scale
change in mindfulness using the 5-Facet Mindfulness Sub-scales [baseline, 8 weeks, 6 months, 12 months]
Examine change in mindfulness between the intervention arms by comparing the responses on the 5-Facet Mindfulness Subscales

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Diagnosed with clinically localized or locally advanced prostate, kidney or bladder cancer OR the spouse/significant other (married or living together ≥ 1 year) of a person with prostate, kidney or bladder cancer
Spouses/significant others will only be included if their partners with cancer diagnoses will be participating
18 years old or older
Proficient in comprehending spoken English. Proficient in reading and writing English.

Exclusion Criteria:

Is not able to receive email or text messages
History of diagnosed severe mental illness or hospitalization for chronic psychiatric reasons, as identified by referring physicians, such that participation in MBSR group activities would be contraindicated.
Vision- or hearing-impaired such that ability to listen to or observe MBSR course instructions is compromised.
Diminished cognitive skills as to render consent meaningless
Physical debilitation such that study participation would not be feasible or would create undue hardship.
Participation in the intervention arm of the preceding study, "Reducing Stress During Active Surveillance" EH09-202.