Trial Outcomes & Findings for Evaluation of Outcomes in Women Undergoing Multimodality Treatment for Advanced Stage Endometrial Carcinoma (NCT NCT04743999)
NCT ID: NCT04743999
Last Updated: 2024-03-29
Results Overview
The Functional Assessment of Cancer Therapy - Endometrial (FACT-EN) questionnaire is a prospectively-validated questionnaire that asks patients to rated the severity of various possible treatment side effects (eg GI pain, pelvic pain, shortness of breath) Scale: 0-4. 0: Not at all, 4: Very much
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
9 participants
Primary outcome timeframe
Baseline, 3-month, 6-month, 12-month, 24-month
Results posted on
2024-03-29
Participant Flow
Participant milestones
| Measure |
Quality of Life Evaluation
This prospective arm will consist of evaluating quality of life outcomes in women in women with advanced endometrial cancer undergoing adjuvant concurrent chemotherapy with carbo/Taxol and radiation therapy. Assessments will occur following surgery (baseline), 3, 6, 12, and 24 months.
Quality of life questionnaire: We will evaluate patients' quality of life with a series of questionnaires at baseline, 3, 6, 12, and 24 months after surgical staging. These are prospectively validated questionnaires and include FACT-G (physical and functional well-being sections), FACT-En (additional concerns section), FACT/GOG-NTX-4 (additional concerns section), and FACT-C (items C3 and C5).These sections will be combined into one single form for ease of completion for the patients (a total of 36 items).
|
|---|---|
|
Baseline Questionnaire
STARTED
|
9
|
|
Baseline Questionnaire
COMPLETED
|
9
|
|
Baseline Questionnaire
NOT COMPLETED
|
0
|
|
3-month Questionnaire
STARTED
|
9
|
|
3-month Questionnaire
COMPLETED
|
8
|
|
3-month Questionnaire
NOT COMPLETED
|
1
|
|
6-month Questionnaire
STARTED
|
8
|
|
6-month Questionnaire
COMPLETED
|
7
|
|
6-month Questionnaire
NOT COMPLETED
|
1
|
|
12-month Questionnaire
STARTED
|
7
|
|
12-month Questionnaire
COMPLETED
|
6
|
|
12-month Questionnaire
NOT COMPLETED
|
1
|
|
24-month Questionnaire
STARTED
|
6
|
|
24-month Questionnaire
COMPLETED
|
1
|
|
24-month Questionnaire
NOT COMPLETED
|
5
|
Reasons for withdrawal
| Measure |
Quality of Life Evaluation
This prospective arm will consist of evaluating quality of life outcomes in women in women with advanced endometrial cancer undergoing adjuvant concurrent chemotherapy with carbo/Taxol and radiation therapy. Assessments will occur following surgery (baseline), 3, 6, 12, and 24 months.
Quality of life questionnaire: We will evaluate patients' quality of life with a series of questionnaires at baseline, 3, 6, 12, and 24 months after surgical staging. These are prospectively validated questionnaires and include FACT-G (physical and functional well-being sections), FACT-En (additional concerns section), FACT/GOG-NTX-4 (additional concerns section), and FACT-C (items C3 and C5).These sections will be combined into one single form for ease of completion for the patients (a total of 36 items).
|
|---|---|
|
3-month Questionnaire
Death
|
1
|
|
6-month Questionnaire
Study terminated due to low accrual
|
1
|
|
12-month Questionnaire
Study terminated due to low accrual
|
1
|
|
24-month Questionnaire
Study terminated due to low accrual
|
5
|
Baseline Characteristics
Evaluation of Outcomes in Women Undergoing Multimodality Treatment for Advanced Stage Endometrial Carcinoma
Baseline characteristics by cohort
| Measure |
Quality of Life Evaluation
n=9 Participants
This prospective arm will consist of evaluating quality of life outcomes in women in women with advanced endometrial cancer undergoing adjuvant concurrent chemotherapy with carbo/Taxol and radiation therapy. Assessments will occur following surgery (baseline), 3, 6, 12, and 24 months.
Quality of life questionnaire: We will evaluate patients' quality of life with a series of questionnaires at baseline, 3, 6, 12, and 24 months after surgical staging. These are prospectively validated questionnaires and include FACT-G (physical and functional well-being sections), FACT-En (additional concerns section), FACT/GOG-NTX-4 (additional concerns section), and FACT-C (items C3 and C5).These sections will be combined into one single form for ease of completion for the patients (a total of 36 items).
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 3-month, 6-month, 12-month, 24-monthThe Functional Assessment of Cancer Therapy - General (FACT-G) questionnaire is a prospectively validated form that assesses physical side effects of treatment (eg pain, nausea, fatigue) as well as treatment's functional impact (eg ability to work, enjoy hobbies). Scale: 0-4. 0: Not at all, 4: Very much Values reported as "0.00 (0.00)" are accurate in all outcome measures.
Outcome measures
| Measure |
Baseline
n=9 Participants
FACT-G (physical and functional well-being sections)
|
3-month
n=8 Participants
FACT-G (physical and functional well-being sections)
|
6-month
n=7 Participants
FACT-G (physical and functional well-being sections)
|
12-month
n=6 Participants
FACT-G (physical and functional well-being sections)
|
24-months
n=1 Participants
FACT-G (physical and functional well-being sections)
|
|---|---|---|---|---|---|
|
Assessment of Physical and Functional Well-being as Assessed by the FACT-G Questionnaire
I have lack of energy
|
0.67 score on a scale
Standard Deviation .47
|
1.63 score on a scale
Standard Deviation 1.32
|
1.43 score on a scale
Standard Deviation 0.90
|
1.67 score on a scale
Standard Deviation 0.94
|
1.00 score on a scale
Standard Deviation 0.00
|
|
Assessment of Physical and Functional Well-being as Assessed by the FACT-G Questionnaire
I have nausea
|
0.22 score on a scale
Standard Deviation 0.42
|
0.38 score on a scale
Standard Deviation 0.70
|
0.00 score on a scale
Standard Deviation 0.00
|
0.50 score on a scale
Standard Deviation 0.76
|
0.00 score on a scale
Standard Deviation 0.00
|
|
Assessment of Physical and Functional Well-being as Assessed by the FACT-G Questionnaire
Because of my physical condition, I have trouble meeting the needs of my family
|
0.44 score on a scale
Standard Deviation 0.83
|
1.00 score on a scale
Standard Deviation 1.50
|
1.00 score on a scale
Standard Deviation 1.41
|
0.67 score on a scale
Standard Deviation 0.75
|
4.00 score on a scale
Standard Deviation 0.00
|
|
Assessment of Physical and Functional Well-being as Assessed by the FACT-G Questionnaire
I have pain
|
0.33 score on a scale
Standard Deviation 0.67
|
1.13 score on a scale
Standard Deviation 1.17
|
1.43 score on a scale
Standard Deviation 1.05
|
1.50 score on a scale
Standard Deviation 0.50
|
4.00 score on a scale
Standard Deviation 0.00
|
|
Assessment of Physical and Functional Well-being as Assessed by the FACT-G Questionnaire
I am bothered by side effects of treatment
|
0.22 score on a scale
Standard Deviation 0.42
|
0.63 score on a scale
Standard Deviation 0.70
|
0.71 score on a scale
Standard Deviation 1.03
|
2.83 score on a scale
Standard Deviation 0.69
|
0.00 score on a scale
Standard Deviation 0.00
|
|
Assessment of Physical and Functional Well-being as Assessed by the FACT-G Questionnaire
I feel ill
|
0.11 score on a scale
Standard Deviation 0.31
|
0.38 score on a scale
Standard Deviation 0.70
|
0.14 score on a scale
Standard Deviation 0.35
|
0.67 score on a scale
Standard Deviation 1.49
|
0.00 score on a scale
Standard Deviation 0.00
|
|
Assessment of Physical and Functional Well-being as Assessed by the FACT-G Questionnaire
I am forced to spend time in bed
|
0.22 score on a scale
Standard Deviation 0.63
|
1.13 score on a scale
Standard Deviation 1.54
|
0.57 score on a scale
Standard Deviation 1.05
|
1.33 score on a scale
Standard Deviation 1.60
|
3.00 score on a scale
Standard Deviation 0.00
|
|
Assessment of Physical and Functional Well-being as Assessed by the FACT-G Questionnaire
I am able to work (include work at home)
|
3.00 score on a scale
Standard Deviation 1.41
|
1.13 score on a scale
Standard Deviation 1.54
|
2.57 score on a scale
Standard Deviation 1.68
|
1.67 score on a scale
Standard Deviation 1.70
|
0.00 score on a scale
Standard Deviation 0.00
|
|
Assessment of Physical and Functional Well-being as Assessed by the FACT-G Questionnaire
My work (include work at home) is fulfilling
|
3.00 score on a scale
Standard Deviation 1.33
|
2.88 score on a scale
Standard Deviation 1.69
|
2.29 score on a scale
Standard Deviation 1.58
|
1.83 score on a scale
Standard Deviation 1.86
|
0.00 score on a scale
Standard Deviation 0.00
|
|
Assessment of Physical and Functional Well-being as Assessed by the FACT-G Questionnaire
I am able to enjoy life
|
3.44 score on a scale
Standard Deviation 0.96
|
3.38 score on a scale
Standard Deviation 0.86
|
2.43 score on a scale
Standard Deviation 1.18
|
2.17 score on a scale
Standard Deviation 1.07
|
2.00 score on a scale
Standard Deviation 0.00
|
|
Assessment of Physical and Functional Well-being as Assessed by the FACT-G Questionnaire
I have accepted my illness
|
3.00 score on a scale
Standard Deviation 1.33
|
3.13 score on a scale
Standard Deviation 1.27
|
2.71 score on a scale
Standard Deviation 1.28
|
3.00 score on a scale
Standard Deviation 1.00
|
3.00 score on a scale
Standard Deviation 0.00
|
|
Assessment of Physical and Functional Well-being as Assessed by the FACT-G Questionnaire
I am sleeping well
|
3.33 score on a scale
Standard Deviation 0.67
|
2.75 score on a scale
Standard Deviation 0.97
|
1.71 score on a scale
Standard Deviation 1.28
|
2.67 score on a scale
Standard Deviation 1.25
|
1.00 score on a scale
Standard Deviation 0.00
|
|
Assessment of Physical and Functional Well-being as Assessed by the FACT-G Questionnaire
I am enjoying the things I usually do for fun
|
3.33 score on a scale
Standard Deviation 0.94
|
2.00 score on a scale
Standard Deviation 1.66
|
2.29 score on a scale
Standard Deviation 1.28
|
1.83 score on a scale
Standard Deviation 1.21
|
0.00 score on a scale
Standard Deviation 0.00
|
|
Assessment of Physical and Functional Well-being as Assessed by the FACT-G Questionnaire
I am content with the quality of my life right now
|
2.88 score on a scale
Standard Deviation 1.69
|
2.00 score on a scale
Standard Deviation 1.73
|
2.00 score on a scale
Standard Deviation 1.60
|
2.17 score on a scale
Standard Deviation 1.21
|
0.00 score on a scale
Standard Deviation 0.00
|
PRIMARY outcome
Timeframe: Baseline, 3-month, 6-month, 12-month, 24-monthThe Functional Assessment of Cancer Therapy - Endometrial (FACT-EN) questionnaire is a prospectively-validated questionnaire that asks patients to rated the severity of various possible treatment side effects (eg GI pain, pelvic pain, shortness of breath) Scale: 0-4. 0: Not at all, 4: Very much
Outcome measures
| Measure |
Baseline
n=9 Participants
FACT-G (physical and functional well-being sections)
|
3-month
n=8 Participants
FACT-G (physical and functional well-being sections)
|
6-month
n=7 Participants
FACT-G (physical and functional well-being sections)
|
12-month
n=6 Participants
FACT-G (physical and functional well-being sections)
|
24-months
n=1 Participants
FACT-G (physical and functional well-being sections)
|
|---|---|---|---|---|---|
|
Assessment of Severity of Various Treatment-related Side Effects as Assessed by the FACT-En Questionnaire
I have swelling in my stomach area
|
0.44 score on a scale
Standard Deviation 0.68
|
0.75 score on a scale
Standard Deviation 1.09
|
0.43 score on a scale
Standard Deviation 0.49
|
1.00 score on a scale
Standard Deviation 1.15
|
0.00 score on a scale
Standard Deviation 0.00
|
|
Assessment of Severity of Various Treatment-related Side Effects as Assessed by the FACT-En Questionnaire
I have cramps in my stomach area
|
0.11 score on a scale
Standard Deviation 0.31
|
0.50 score on a scale
Standard Deviation 0.71
|
0.14 score on a scale
Standard Deviation 0.35
|
0.67 score on a scale
Standard Deviation 1.11
|
0.00 score on a scale
Standard Deviation 0.00
|
|
Assessment of Severity of Various Treatment-related Side Effects as Assessed by the FACT-En Questionnaire
I have discomfort or pain in my stomach area
|
0.33 score on a scale
Standard Deviation 0.67
|
0.63 score on a scale
Standard Deviation 0.86
|
0.43 score on a scale
Standard Deviation 0.49
|
1.00 score on a scale
Standard Deviation 1.15
|
0.00 score on a scale
Standard Deviation 0.00
|
|
Assessment of Severity of Various Treatment-related Side Effects as Assessed by the FACT-En Questionnaire
I have vaginal bleeding or spotting
|
0.00 score on a scale
Standard Deviation 0.00
|
0.00 score on a scale
Standard Deviation 0.00
|
0.00 score on a scale
Standard Deviation 0.00
|
0.00 score on a scale
Standard Deviation 0.00
|
0.00 score on a scale
Standard Deviation 0.00
|
|
Assessment of Severity of Various Treatment-related Side Effects as Assessed by the FACT-En Questionnaire
I have vaginal discharge
|
0.11 score on a scale
Standard Deviation 0.31
|
0.13 score on a scale
Standard Deviation 0.33
|
0.14 score on a scale
Standard Deviation 0.35
|
0.00 score on a scale
Standard Deviation 0.00
|
0.00 score on a scale
Standard Deviation 0.00
|
|
Assessment of Severity of Various Treatment-related Side Effects as Assessed by the FACT-En Questionnaire
I am unhappy about a change in my appearance
|
0.22 score on a scale
Standard Deviation 0.42
|
1.25 score on a scale
Standard Deviation 1.64
|
0.71 score on a scale
Standard Deviation 0.70
|
1.83 score on a scale
Standard Deviation 1.67
|
0.00 score on a scale
Standard Deviation 0.00
|
|
Assessment of Severity of Various Treatment-related Side Effects as Assessed by the FACT-En Questionnaire
I have hot flashes/hot flushes
|
0.56 score on a scale
Standard Deviation 1.07
|
0.38 score on a scale
Standard Deviation 0.48
|
0.43 score on a scale
Standard Deviation 0.49
|
0.17 score on a scale
Standard Deviation 0.37
|
0.00 score on a scale
Standard Deviation 0.00
|
|
Assessment of Severity of Various Treatment-related Side Effects as Assessed by the FACT-En Questionnaire
I have cold sweats
|
0.11 score on a scale
Standard Deviation 0.31
|
0.25 score on a scale
Standard Deviation 0.43
|
0.00 score on a scale
Standard Deviation 0.00
|
0.17 score on a scale
Standard Deviation 0.37
|
0.00 score on a scale
Standard Deviation 0.00
|
|
Assessment of Severity of Various Treatment-related Side Effects as Assessed by the FACT-En Questionnaire
I have night sweats
|
0.67 score on a scale
Standard Deviation 1.05
|
0.75 score on a scale
Standard Deviation 0.97
|
0.57 score on a scale
Standard Deviation 0.73
|
0.50 score on a scale
Standard Deviation 0.50
|
0.00 score on a scale
Standard Deviation 0.00
|
|
Assessment of Severity of Various Treatment-related Side Effects as Assessed by the FACT-En Questionnaire
I feel fatigued
|
1.00 score on a scale
Standard Deviation 0.94
|
1.25 score on a scale
Standard Deviation 1.20
|
0.86 score on a scale
Standard Deviation 0.83
|
1.67 score on a scale
Standard Deviation 0.94
|
0.00 score on a scale
Standard Deviation 0.00
|
|
Assessment of Severity of Various Treatment-related Side Effects as Assessed by the FACT-En Questionnaire
I have pain or discomfort with intercourse
|
0.11 score on a scale
Standard Deviation 0.31
|
0.38 score on a scale
Standard Deviation 0.99
|
0.14 score on a scale
Standard Deviation 0.35
|
0.67 score on a scale
Standard Deviation 1.49
|
0.00 score on a scale
Standard Deviation 0.00
|
|
Assessment of Severity of Various Treatment-related Side Effects as Assessed by the FACT-En Questionnaire
I have trouble digesting food
|
0.00 score on a scale
Standard Deviation 0.00
|
0.38 score on a scale
Standard Deviation 0.70
|
0.29 score on a scale
Standard Deviation 0.45
|
0.33 score on a scale
Standard Deviation 0.47
|
0.00 score on a scale
Standard Deviation 0.00
|
|
Assessment of Severity of Various Treatment-related Side Effects as Assessed by the FACT-En Questionnaire
I have been short of breath
|
0.33 score on a scale
Standard Deviation 0.67
|
0.38 score on a scale
Standard Deviation 0.48
|
0.14 score on a scale
Standard Deviation 0.35
|
0.33 score on a scale
Standard Deviation 0.47
|
0.00 score on a scale
Standard Deviation 0.00
|
|
Assessment of Severity of Various Treatment-related Side Effects as Assessed by the FACT-En Questionnaire
I am bothered by constipation
|
1.22 score on a scale
Standard Deviation 1.55
|
1.50 score on a scale
Standard Deviation 1.73
|
0.43 score on a scale
Standard Deviation 1.05
|
1.67 score on a scale
Standard Deviation 1.70
|
3.00 score on a scale
Standard Deviation 0.00
|
|
Assessment of Severity of Various Treatment-related Side Effects as Assessed by the FACT-En Questionnaire
I urinate more frequently than usual
|
0.56 score on a scale
Standard Deviation 0.96
|
1.00 score on a scale
Standard Deviation 1.00
|
0.86 score on a scale
Standard Deviation 1.36
|
1.33 score on a scale
Standard Deviation 1.11
|
0.00 score on a scale
Standard Deviation 0.00
|
|
Assessment of Severity of Various Treatment-related Side Effects as Assessed by the FACT-En Questionnaire
I have discomfort or pain in my pelvic area
|
0.33 score on a scale
Standard Deviation 0.67
|
1.13 score on a scale
Standard Deviation 1.17
|
0.57 score on a scale
Standard Deviation 1.05
|
0.67 score on a scale
Standard Deviation 1.11
|
0.00 score on a scale
Standard Deviation 0.00
|
PRIMARY outcome
Timeframe: Baseline, 3-month, 6-month, 12-month, 24-monthThe Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity 4 Item Version (FACT/GOG-NTX-4) scale is a prospectively-validated questionnaire that assesses the severity of side effects related to neurotoxicity (paresthesia, pain in hands/feet) Scale: 0-4. 0: Not at all, 4: Very much
Outcome measures
| Measure |
Baseline
n=9 Participants
FACT-G (physical and functional well-being sections)
|
3-month
n=8 Participants
FACT-G (physical and functional well-being sections)
|
6-month
n=7 Participants
FACT-G (physical and functional well-being sections)
|
12-month
n=6 Participants
FACT-G (physical and functional well-being sections)
|
24-months
n=1 Participants
FACT-G (physical and functional well-being sections)
|
|---|---|---|---|---|---|
|
Assessment of Severity of Neurotoxicity Side Effects as Assessed by the FACT/GOG-NTX-4 Scale
I have numbness or tingling in my hands
|
0.44 score on a scale
Standard Deviation 0.68
|
1.63 score on a scale
Standard Deviation 1.58
|
1.71 score on a scale
Standard Deviation 1.28
|
2.33 score on a scale
Standard Deviation 1.37
|
0.00 score on a scale
Standard Deviation 0.00
|
|
Assessment of Severity of Neurotoxicity Side Effects as Assessed by the FACT/GOG-NTX-4 Scale
I have numbness or tingling in my feet
|
0.78 score on a scale
Standard Deviation 1.03
|
2.50 score on a scale
Standard Deviation 1.73
|
2.71 score on a scale
Standard Deviation 1.03
|
3.17 score on a scale
Standard Deviation 0.90
|
4.00 score on a scale
Standard Deviation 0.00
|
|
Assessment of Severity of Neurotoxicity Side Effects as Assessed by the FACT/GOG-NTX-4 Scale
I feel discomfort in my hands
|
0.33 score on a scale
Standard Deviation 0.67
|
0.88 score on a scale
Standard Deviation 1.05
|
1.29 score on a scale
Standard Deviation 0.88
|
1.67 score on a scale
Standard Deviation 1.37
|
0.00 score on a scale
Standard Deviation 0.00
|
|
Assessment of Severity of Neurotoxicity Side Effects as Assessed by the FACT/GOG-NTX-4 Scale
I feel discomfort in my feet
|
1.00 score on a scale
Standard Deviation 1.25
|
1.88 score on a scale
Standard Deviation 1.76
|
1.71 score on a scale
Standard Deviation 1.48
|
2.83 score on a scale
Standard Deviation 1.46
|
1.00 score on a scale
Standard Deviation 0.00
|
PRIMARY outcome
Timeframe: Baseline, 3-month, 6-month, 12-month, 24-monthThe Functional Assessment of Cancer Therapy - Colorectal (FACT-C) scale is a prospectively-validated questionnaire that asses GI-related side effects (diarrhea, fecal incontinence) Scale: 0-4. 0: Not at all, 4: Very much
Outcome measures
| Measure |
Baseline
n=9 Participants
FACT-G (physical and functional well-being sections)
|
3-month
n=8 Participants
FACT-G (physical and functional well-being sections)
|
6-month
n=7 Participants
FACT-G (physical and functional well-being sections)
|
12-month
n=6 Participants
FACT-G (physical and functional well-being sections)
|
24-months
n=1 Participants
FACT-G (physical and functional well-being sections)
|
|---|---|---|---|---|---|
|
Assessment of Severity of GI Side Effects as Assessed by the FACT-C Questionnaire
I have control of my bowels
|
4.00 score on a scale
Standard Deviation 0.00
|
2.25 score on a scale
Standard Deviation 1.79
|
2.57 score on a scale
Standard Deviation 1.76
|
3.33 score on a scale
Standard Deviation 0.94
|
4.00 score on a scale
Standard Deviation 0.00
|
|
Assessment of Severity of GI Side Effects as Assessed by the FACT-C Questionnaire
I have diarrhea
|
0.56 score on a scale
Standard Deviation 1.07
|
1.00 score on a scale
Standard Deviation 1.50
|
0.43 score on a scale
Standard Deviation 0.49
|
0.33 score on a scale
Standard Deviation 0.47
|
0.00 score on a scale
Standard Deviation 0.00
|
Adverse Events
Quality of Life Evaluation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place