This clinical trial studies the feasibility of using hypo-fractionated radiotherapy for the treatment of cervical or endometrial cancer. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects.
PRIMARY OBJECTIVE: I. To establish the trial as feasible and to assess the impact upon acute gastrointestinal toxicity in the third week of pelvic radiotherapy following a hypo-fractionated schedule. SECODARY OBJECTIVES: I. To estimate impact upon acute urinary toxicity. II. To estimate impact upon patient reported gastrointestional toxicity. III. To assess acute quality of life following treatment. IV. To quantify acute financial toxicity following treatment. V. To assess satisfaction with decision-making following treatment. VI. To assess the overall survival throughout 3 years of post-treatment follow-up. OUTLINE: Patients undergo hypo-fractionated radiotherapy over 3 weeks in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 1, 3, and 6 months and then at 1, 2, and 3 years.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
22
Undergo hypofractionated radiation therapy
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, United States
Change in Toxicity - Bowel Summary Score
Change in toxicity will be measured by the change in bowel domain score as assessed on the Expanded Prostate Cancer Index Composite (EPIC) instrument. EPIC is a 26-item, self-assessed questionnaire rated on a 5-point Likert scale. 14 items in this assessment create the Bowel Summary score. Bowel Summary scores are transformed linearly to a 0-100 scale, with higher scores indicating better Health-related Quality of Life (HRQOL) and lower scores indicating worse HRQOL. This outcome measure will report mean change in the Bowel Summary Score. A positive change indicates the scores increased (improved HRQOL) and a negative Change indicates the scores decreased (worse HRQOL). This outcome measure will report mean EPIC Bowel Summary scores at the week 3 timepoint.
Time frame: from baseline to the week 3 timepoint, up to 6 weeks from the baseline visit
Trial Feasibility - Number of Evaluable Patients
To assess the feasibility of administering a clinical trial to evaluate hypofractionated radiotherapy. This outcome measure will report the number of evaluable patients and the number of patients who started study treatment but were not deemed evaluable. To be considered evaluable, an eligible patient must have completed 3 weeks of treatment and completed EPIC bowel domain questionnaire at baseline and 3 weeks.
Time frame: Baseline to week 3 (up to 6 weeks from the baseline visit)
Change in Urinary Domain of the Expanded Prostate Cancer Index Composite (EPIC) Instrument
Change in urinary toxicity will be measured by the change in urinary summary score as assessed on the Expanded Prostate Cancer Index Composite (EPIC) instrument. EPIC is a 26-item, self-assessed questionnaire rated on a 5-point Likert scale. 10 items in this assessment create the Urine Summary score. Urine Summary scores are transformed linearly to a 0-100 scale, with higher scores indicating better Health-related Quality of Life (HRQOL) and lower scores indicating worse HRQOL. This outcome measure will report mean change in the Urine Summary Score. A positive change indicates the scores increased (improved HRQOL) and a negative Change indicates the scores decreased (worse HRQOL). This outcome measure will report mean EPIC Urine Summary scores at the week 3 and 1 year timepoint.
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Time frame: Baseline to week 3 (up to 6 weeks from the baseline visit) and 1 year (up to 14 months from the baseline visit)
Change in Bowel Domain of the Expanded Prostate Cancer Index Composite (EPIC) Instrument
Change in toxicity will be measured by the change in bowel domain score as assessed on the Expanded Prostate Cancer Index Composite (EPIC) instrument. EPIC is a 26-item, self-assessed questionnaire rated on a 5-point Likert scale. 14 items in this assessment create the Bowel Summary score. Bowel Summary scores are transformed linearly to a 0-100 scale, with higher scores indicating better Health-related Quality of Life (HRQOL) and lower scores indicating worse HRQOL. This outcome measure will report mean change in the Bowel Summary Score. A positive change indicates the scores increased (improved HRQOL) and a negative Change indicates the scores decreased (worse HRQOL). This outcome measure will report mean EPIC Bowel Summary scores at the week 3 timepoint.
Time frame: Baseline to 1 year (up to 14 months from the baseline visit)
Patient-Reported Outcomes Instruments (PRO-CTCAE) - OFTEN Loose or Watery Stools (Diarrhea)
To estimate the impact upon patient reported gastrointestinal toxicities as collected through Patient-Reported Outcomes (PRO-CTCAE) instruments. This outcome measure is a single item assessing how OFTEN participants experienced Loose or Watery Stools (Diarrhea) in the last 7 days. The count of participants will be reported at week 3 (up to 6 weeks from the baseline visit) and 1 year (up to 14 months from the baseline visit).
Time frame: Baseline to week 3 (up to 6 weeks from the baseline visit) and 1 year (up to 14 months from the baseline visit)
Patient-Reported Outcomes Instruments (PRO-CTCAE) - OFTEN Pain in the Abdomen
To estimate the impact upon patient reported gastrointestinal toxicities as collected through Patient-Reported Outcomes (PRO-CTCAE) instruments. This outcome measure is a single item assessing how OFTEN participants experienced Pain in the Abdomen (Belly Area) in the last 7 days. The count of participants will be reported at week 3 (up to 6 weeks from the baseline visit) and 1 year (up to 14 months from the baseline visit).
Time frame: Baseline to week 3 (up to 6 weeks from the baseline visit) and 1 year (up to 14 months from the baseline visit)
Patient-Reported Outcomes Instruments (PRO-CTCAE) - SEVERITY Pain in the Abdomen
To estimate the impact upon patient reported gastrointestinal toxicities as collected through Patient-Reported Outcomes (PRO-CTCAE) instruments. This outcome measure is a single item assessing the SEVERITY of participants' Pain in the Abdomen (Belly Area) at its WORST in the last 7 days. The count of participants will be reported at week 3 (up to 6 weeks from the baseline visit) and 1 year (up to 14 months from the baseline visit).
Time frame: Baseline to week 3 (up to 6 weeks from the baseline visit) and 1 year (up to 14 months from the baseline visit)
Patient-Reported Outcomes Instruments (PRO-CTCAE) - INTERFERE Pain in the Abdomen
To estimate the impact upon patient reported gastrointestinal toxicities as collected through Patient-Reported Outcomes (PRO-CTCAE) instruments. This outcome measure is a single item assessing how much Pain in the Abdomen (Belly Area) INTERFERED with their usual or daily activities in the last 7 days. The count of participants will be reported at week 3 (up to 6 weeks from the baseline visit) and 1 year (up to 14 months from the baseline visit).
Time frame: Baseline to week 3 (up to 6 weeks from the baseline visit) and 1 year (up to 14 months from the baseline visit)
Patient-Reported Outcomes Instruments (PRO-CTCAE) - OFTEN Lose Control of Bowel Movement
To estimate the impact upon patient reported gastrointestinal toxicities as collected through Patient-Reported Outcomes (PRO-CTCAE) instruments. This outcome measure is a single item assessing how OFTEN participants experienced Lose Control of Bowel Movement in the last 7 days. The count of participants will be reported at week 3 (up to 6 weeks from the baseline visit) and 1 year (up to 14 months from the baseline visit).
Time frame: Baseline to week 3 (up to 6 weeks from the baseline visit) and 1 year (up to 14 months from the baseline visit)
Patient-Reported Outcomes Instruments (PRO-CTCAE) - INTERFERE Loss of Control of Bowel Movement Interfere
To estimate the impact upon patient reported gastrointestinal toxicities as collected through Patient-Reported Outcomes (PRO-CTCAE) instruments. This outcome measure is a single item assessing how much Loss of Control of Bowel Movement Interfere INTERFERED with their usual or daily activities in the last 7 days. The count of participants will be reported at week 3 (up to 6 weeks from the baseline visit) and 1 year (up to 14 months from the baseline visit).
Time frame: Baseline to week 3 (up to 6 weeks from the baseline visit) and 1 year (up to 14 months from the baseline visit)
Change in Functional Assessment of Cancer Therapy-Cervix (FACT-Cx)
To assess acute and 1 year quality of life following treatment as assessed on the Functional Assessment of Cancer Therapy-Cervix (FACT-Cx). FACT-Cx is a 42-item, self-assessed questionnaire rated on a 5-point Likert scale. FACT-Cx total scores range from 0-168, with higher scores indicating better Quality of Life (QOL) and lower scores indicating worse QOL This outcome measure will report the mean change in the FACT-Cx Total Score at the week 3 (up to 6 weeks from the baseline visit) and 1 year (up to 14 months from the baseline visit) timpoints. A positive change indicates the scores increased (improved QOL), and a negative Change indicates the scores decreased (worse QOL).
Time frame: Baseline to week 3 (up to 6 weeks from the baseline visit) and 1 year (up to 14 months from the baseline visit)
Change in FACIT Measure of Financial Toxicity (FACIT-COST) Score
To assess acute and 1 year quality of life following treatment as assessed on the FACIT Measure of Financial Toxicity (FACIT-COST). FACT-COST is a 12-item, self-assessed questionnaire rated on a 5-point Likert scale. FACT-COST Score ranges from 0-44, with higher scores indicating better financial well-being and lower scores indicating worse financial well-being. This outcome measure will report the mean change in the FACT-COST Score at the week 3 (up to 6 weeks from the baseline visit) and 1 year (up to 14 months from the baseline visit) time points. A positive change indicates the scores increased (better financial well-being), and a negative Change indicates the scores decreased (worse financial well-being).
Time frame: Baseline to week 3 (up to 6 weeks from the baseline visit) and 1 year (up to 14 months from the baseline visit)
Decision Regret Scale - Summary Score
To assess acute and 1 year satisfaction with decision-making following treatment. The Decision Regret Scale is a 5-item, self-assessed questionnaire rated on a 5-point Likert scale. Decision Regret Scale Score ranges from 0-100, with higher scores indicating high regret and lower scores indicating less regret. This outcome measure will report the mean Decision Regret Scale Score at the week 3 (up to 6 weeks from the baseline visit) and 1 year (up to 14 months from the baseline visit) time points.
Time frame: Baseline to week 3 (up to 6 weeks from the baseline visit) and 1 year (up to 14 months from the baseline visit)
Overall Survival
Will use the Kaplan-Meier method to estimate overall survival throughout three years from the time of completing treatment.
Time frame: Time to the earliest of all-cause mortality (event), end of study follow-up (censoring criteria), or loss to follow-up (censoring criteria), assessed up to 3 years