Trial Outcomes & Findings for Healing Touch in Treating Fatigue in Women Undergoing Radiation Therapy for Breast Cancer (NCT NCT00574145)

Results Overview

9-items with an 11-point rating scale measures intensity of fatigue (3 items, 0 = no fatigue to 10 = fatigue as bad as you can imagine) and interference of fatigue on daily life (6 items, 0 = does not interfere to 10 = completely interferes. Each participant's score is summed with a possible minimum score of 0 and a possible maximum score of 90. A mean score was then determined.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

44 participants

Primary outcome timeframe

6 weeks

Results posted on

2012-09-06

Participant Flow

This study enrolled February 2007 to March 2009.

Forty-four patients signed consent, all were eligible.

Participant milestones

Participant milestones
Measure	Radiotherapy/Supportive Care (A) Patients receive radiotherapy and healing touch therapy from a healing touch therapist once a week for the duration of their radiotherapy	Control ARM (B) Patients receive radiotherapy and sham healing touch therapy from a sham healing touch therapist once a week for the duration of their radiotherapy
Overall Study STARTED	22	22
Overall Study COMPLETED	20	21
Overall Study NOT COMPLETED	2	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Radiotherapy/Supportive Care (A) Patients receive radiotherapy and healing touch therapy from a healing touch therapist once a week for the duration of their radiotherapy	Control ARM (B) Patients receive radiotherapy and sham healing touch therapy from a sham healing touch therapist once a week for the duration of their radiotherapy
Overall Study Withdrawal by Subject	2	1

Baseline Characteristics

Healing Touch in Treating Fatigue in Women Undergoing Radiation Therapy for Breast Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Radiotherapy/Supportive Care (A) n=22 Participants Patients receive radiotherapy and healing touch therapy from a healing touch therapist once a week for the duration of their radiotherapy	Control ARM (B) n=22 Participants Patients receive radiotherapy and sham healing touch therapy from a sham healing touch therapist once a week for the duration of their radiotherapy	Total n=44 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	21 Participants n=93 Participants	21 Participants n=4 Participants	42 Participants n=27 Participants
Age, Categorical >=65 years	1 Participants n=93 Participants	1 Participants n=4 Participants	2 Participants n=27 Participants
Age Continuous	50 years STANDARD_DEVIATION 1 • n=93 Participants	51 years STANDARD_DEVIATION 1 • n=4 Participants	51 years STANDARD_DEVIATION 1 • n=27 Participants
Sex: Female, Male Female	22 Participants n=93 Participants	22 Participants n=4 Participants	44 Participants n=27 Participants
Sex: Female, Male Male	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Region of Enrollment United States	22 participants n=93 Participants	22 participants n=4 Participants	44 participants n=27 Participants

PRIMARY outcome

Timeframe: 6 weeks

Population: Patients who completed 5 of 8 maximum collection points. Arm A: 1 patient withdrew at 2 days, 1 patient withdrew at 5 days. Arm B: 1 patient withdrew at 4 weeks

9-items with an 11-point rating scale measures intensity of fatigue (3 items, 0 = no fatigue to 10 = fatigue as bad as you can imagine) and interference of fatigue on daily life (6 items, 0 = does not interfere to 10 = completely interferes. Each participant's score is summed with a possible minimum score of 0 and a possible maximum score of 90. A mean score was then determined.

Outcome measures

Outcome measures
Measure	Radiotherapy/Supportive Care (A) n=20 Participants Patients receive radiotherapy and healing touch therapy from a healing-touch therapist once a week for the duration of their radiotherapy	Control ARM (B) n=21 Participants Patients receive radiotherapy and sham healing touch therapy from a sham healing-touch therapist once a week for the duration of their radiotherapy
Fatigue Using the Brief Fatigue Inventory (BFI)	2.786 units on a scale Standard Deviation 0.1963	1.356 units on a scale Standard Deviation 0.1413

SECONDARY outcome

Timeframe: baseline and 6 weeks

Population: Arm A:1 patient was accidentally notified of group assignment before final data collected, 2 patients withdrew (1 at 2 days), 1 at 5 days. )Arm B: 1 patient withdrew at 4 weeks

36 items that measure general quality of life (27 items) and specific breast cancer concerns (9 items) on a 5-point rating scale with 0 = not at all to 4 = very much. Minimum (worst quality of life) possible score = 0 and maximum (best quality of life) possible score = 144. Physical and emotional well-being scores were reverse coded and sub scale scores were summed. Median scores for baseline and at 6 weeks were determined

Outcome measures

Outcome measures
Measure	Radiotherapy/Supportive Care (A) n=20 Participants Patients receive radiotherapy and healing touch therapy from a healing-touch therapist once a week for the duration of their radiotherapy	Control ARM (B) n=21 Participants Patients receive radiotherapy and sham healing touch therapy from a sham healing-touch therapist once a week for the duration of their radiotherapy
Quality of Life as Measured by the Functional Assessment of Cancer Therapy-Breast Form (FACT-B) Baseline	61 units on a scale Interval 50.0 to 85.0	65 units on a scale Interval 54.0 to 76.0
Quality of Life as Measured by the Functional Assessment of Cancer Therapy-Breast Form (FACT-B) 6 Weeks	65 units on a scale Interval 44.0 to 76.0	67 units on a scale Interval 44.0 to 77.0

SECONDARY outcome

Timeframe: baseline and off-radiation at 5 to 7 weeks

Population: Arm A: 1 patient withdrew at 2 days, 1 patient withdrew at 5 days. Arm B: 1 patient withdrew at 4 weeks

Measured on the Hospital Anxiety and Depression Scale, 14 items on a 4-point scale scored from 0 = not at all (best feeling) to 3 = very often (worst feeling). Scores are summed and range from a minimum of 0 (no anxiety or depression) to 42 (worst anxiety or depression)and a median for each arm is determined at the specified timepoints.

Outcome measures

Outcome measures
Measure	Radiotherapy/Supportive Care (A) n=20 Participants Patients receive radiotherapy and healing touch therapy from a healing-touch therapist once a week for the duration of their radiotherapy	Control ARM (B) n=21 Participants Patients receive radiotherapy and sham healing touch therapy from a sham healing-touch therapist once a week for the duration of their radiotherapy
Intensity of Anxiety and Depression Baseline	21 units on a scale Interval 16.0 to 28.0	23 units on a scale Interval 16.0 to 29.0
Intensity of Anxiety and Depression At 5 to 7 weeks	28 units on a scale Interval 21.0 to 40.0	28 units on a scale Interval 21.0 to 37.0

Adverse Events

Radiotherapy/Supportive Care (A)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control ARM (B)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Nancy Wells, DNSc., R.N

Vanderbilt-Ingram Cancer Center

Phone: 615-322-6184

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place